Form 8-K

8-K — SS Innovations International, Inc.

Accession: 0001213900-26-108792

Filed: 2026-10-13

Period: 2026-10-13

CIK: 0001676163

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0308357-8k_ssinnova.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED OCTOBER 13, 2026 (ea030835701ex99-1.htm)

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8-K — CURRENT REPORT

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

8-K

Pursuant

to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date

of report (Date of earliest event reported): October 13, 2026

INNOVATIONS INTERNATIONAL, INC.

(Exact

name of registrant as specified in its charter)

Florida

001-42615

47-3478854

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

405,

3rd Floor, iLabs Info Technology Centre

Udyog

Vihar, Phase III

Gurugram,

Haryana India

122016

(Address of Principal Executive

Offices)

(Zip Code)

Registrant’s

telephone number, including area code: +91 73375 53469

(Former

name or former address, if changed since last report)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions (see General Instruction A.2. below):

☐

Written communications

pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant

to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications

pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications

pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each Class

Trading

Symbol

Name

of each exchange on which registered

Common Stock

SSII

The Nasdaq Stock Market

LLC

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

used in this Current Report on Form 8-K (this “Current Report”), the terms “SSi,” “the

Company,” “we,” “us” and “our” refer to SS Innovations International,

Inc. and its subsidiaries.

Item

8.01 Other Events.

October 13, 2026, SSi issued a press release announcing that, on October 5, 2026, the Company submitted its response to a request for

additional information letter received from the United States Food and Drug Administration with respect to its 510(k) application for

SSi’s SSi Mantra surgical robotic system.

copy of the press release is included as Exhibit 99.1 to this Current Report.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit No.

Description

99.1

Press Release, dated October 13, 2026

104

Cover Page Interactive

Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

Dated: October 13, 2026

SS INNOVATIONS INTERNATIONAL, INC.

By:

/s/

Sudhir Srivastava

Sudhir Srivastava, M.D.

Chairman and Chief Executive

Officer

EX-99.1 — PRESS RELEASE, DATED OCTOBER 13, 2026

EX-99.1

Filename: ea030835701ex99-1.htm · Sequence: 2

Exhibit

99.1

Innovations Submits Response to FDA Request for Additional Information Regarding the Company’s 510(k) Submission for the SSi Mantra

FORT

LAUDERDALE, Fla. – October 13, 2026 –

SS Innovations International, Inc. (the “Company” or “SS Innovations”) (NASDAQ: SSII),

a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population,

today announced that, on October 5, 2026, the Company submitted its response to a request for additional information letter (the “AINN”)

received from the United States Food and Drug Administration (the “FDA”) with regard to the Company’s 510(k)

submission for its SSi Mantra surgical robotic system (the “SSi Mantra”).

The

Company’s response to the AINN includes final data from an expanded human clinical and human factors validation study (the “Study”)

for the SSi Mantra. The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA’s

requirements for safety, efficacy and feasibility, and is an important part of the Company’s 510(k) premarket notification.

The

Company’s response to the AINN also includes final data from a bridging study (the “Bridging Study”), which

the Company completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network located in Bucaramanga,

Colombia.

The

Company anticipates that the FDA will complete its review of the Company’s AINN response and the Company’s 510(k) submission

for the SSi Mantra in the first quarter of 2027.

The

Company engaged Daniel & Daniel Consulting, LLC to assist with the AINN response, the Study, the Bridging Study, and the 510(k) submission,

which covers the initial indication of cholecystectomy (gallbladder removal).

Dr.

Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “In response to the FDA’s

request for additional information, we completed an expanded human clinical and human factors validation study for our SSi Mantra surgical

robotic system. Our response to the FDA’s AINN brings us closer to our goal of introducing our advanced, cost-efficient SSi Mantra

surgical robotic system to the U.S. market.”

About

SS Innovations

Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of

robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its

proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments,

which support a variety of surgical robotic procedures including cardiac surgery. Headquartered in India, SS Innovations is a U.S. company

focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions.

Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.

About

the SSi Mantra

The

SSi Mantra surgical robotic system is a modular, multi-arm system with advanced technology features, including: 3 to 5 modular robotic

arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information

display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic

imaging. The optional SSi MantrAsana tele-surgeon console is a portable, compact alternative to the SSi Mantra’s standard surgeon

command center that is intended to provide equivalent control functionality while enabling enhanced portability, ergonomic flexibility,

and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different

specialties, including cardiac surgery, and 5mm instruments for the pediatric population and ENT surgeries. A vision cart is designed

to provide the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra

has been clinically validated in India in more than 190 different types of surgical procedures.

Forward

Looking Statements

This

press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private

Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,”

“expect,” “will,” “intend,” “may,” “plan,” “project,” “should,”

“could,” “seek,” “designed,” “potential,” “forecast,” “target,”

“objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking

statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown

risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially

different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

Investor

Contact:

The

Equity Group

Kalle

Ahl, CFA

(303) 953-9878

kalle.ahl@theequitygroup.com

Devin

Sullivan, Managing Director

(212) 836-9608

devin.sullivan@theequitygroup.com

Media

Contact:

RooneyPartners

LLC

Kate

Barrette

(212) 223-0561

kbarrette@rooneypartners.com

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