Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007887711

FEI Number

3007887711

Entity Name

SWISSORTHO LLC

City/State/Country

Providence, RI, US

Establishment Address

18 Imperial Place, Suite 1G, Providence, RI 02903, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

S2S Surgical LLC (Owner Number: 10028517)

Owner / Operator Contact Address

1503 South County Trail, East Greenwich, RI 02818, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FaST CTR system WRIST TABLE TFR RETRACTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-01-30
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2009-02-06
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2009-08-03

Official Correspondent

Ann Marie Anastacio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

S2S Surgical LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3008816725	STRAUSS SURGICAL USA LLC.	Doral, FL, US
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3008886285	Flextronics International Kft	Budapest, HU
3012574325	HAKAMA AG	Baettwil Solothurn, CH
3001397320	ROECHLING MEDICAL ROCHESTER L.P.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007887711. Last updated year: 2026. Please use registration number 3007887711 when referencing this establishment in official correspondence.