Who else makes this device?

Name: Handle S
Brand: Handle S

Orthopedic › ProstheticFastener, Fixation, Biodegradable, Soft Tissue

Handle S

Handle with AO-Coupling for the Geomax Reamer S-PI-Axx (tips) for SF Push-in Anchor Portfolio

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

All of them in Shanghai.

Chinese manufacturers registered for FDA product code MAI
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38

Record

Regulatory record for Handle S
Listed by	Surgical Fusion Technologies GmbH, Switzerland
FDA product code	MAI
Device type	Fastener, Fixation, Biodegradable, Soft Tissue
Device class	Class 2
Regulation	21 CFR 888.3030
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K240288
Record published	2025-10-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Handle S
Catalogue number	Size	Status
S		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arthrex®	Arthrex, Inc.	545
Fix2Lock	Osteonic Co., Ltd.	118
Delta	Stryker Leibinger Gmbh & Co. KG	110
Reunite Screw System	Biomet Orthopedics	85
ComposiTCP	S.B.M	61
ActivaScrew™ Interference	Bioretec Ltd.	54
Ligafix	S.B.M	40
Twinfix	Smith & Nephew, Inc.	28
Biosure	Smith & Nephew, Inc.	27
TorqLoc Interference	Bioretec Ltd.	27
FiberFIX	Nanova BIO Materials Inc	25
AlphaVent	Stryker GmbH	23

Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260294	2026-03-27
K240288	2024-04-01

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.