FibFix

Threaded 4.7mm x 190mm (Sterile)

Registry build 21.09.26
3manufacturers in China registered for this device type
26catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JDS
Manufacturer City Province Registered as Device types
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54

Record

Regulatory record for FibFix
Listed by Fusion Orthopedics, LLC, United States
FDA product code JDS
Device type Nail, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3030
510(k) K252961
Record published 2026-04-08

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for FibFix
Catalogue number Size Status
FN-TH-4719-S In distribution
FN-TH-5715-S In distribution
FN-TH-4715 In distribution
FN-TH-5715 In distribution
FN-TH-5723-S In distribution
FN-TH-3723 In distribution
FN-TH-5719 In distribution
FN-TH-3715 In distribution
FN-TH-3713-S In distribution
FN-TH-3727 In distribution
FN-TH-3719 In distribution
FN-TH-3713 In distribution
FN-TH-5727 In distribution
FN-TH-3719-S In distribution
FN-TH-4727-S In distribution
FN-TH-4727 In distribution
FN-TH-3727-S In distribution
FN-TH-3723-S In distribution
FN-TH-3715-S In distribution
FN-TH-5719-S In distribution
FN-TH-4723 In distribution
FN-TH-5727-S In distribution
FN-TH-4715-S In distribution
FN-TH-5723 In distribution
FN-TH-4723-S In distribution
FN-TH-4719 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Autobahn Globus Medical, Inc. 1,102
Trigen Smith & Nephew, Inc. 1,062
Nail, Fixation, Bone Synthes Gmbh 296
Nail, Fixation, Bone Synthes (U.S.A.) LP 237
Intertan MAX Smith & Nephew, Inc. 235
EXPert Nail Synthes Gmbh 225
Trigen MAX Smith & Nephew, Inc. 172
Ajax Nail Auxein medical Private limited 168
GPC GPC Medical Limited 155
130° Ga-mma Nail Auxein medical Private limited 90
Ender Nail Smith & Nephew, Inc. 82
Centronail Titanium Humeral Nailing System Orthofix SRL 79

Showing 12 of 112. All products under Nail, Fixation, Bone

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer