Ga-Mma Nail

Ø6.4mm Cannulated Anti-Rotation Screw, Length 100mm, Titanium (For Anti-Rotation Ga-mma Nail)

Registry build 21.09.26
17manufacturers in China registered for this device type
53catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HSB
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70

Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories

Record

Regulatory record for Ga-mma Nail
Listed by Auxein medical Private limited, India
FDA product code HSB
Device type Rod, Fixation, Intramedullary And Accessories
Device class Class 2
Regulation 21 CFR 888.3020
Establishment Complaint-file establishment, Manufacturer
510(k) K192003
Record published 2020-10-23
Record revised 2025-02-06 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Ga-mma Nail
Catalogue number Size Status
TI-600-026 In distribution
TI-600-040 In distribution
TI-600A-6.4-100 In distribution
TI-1457-001E In distribution
TI-1457-005E In distribution
TI-600-075 In distribution
TI-600-080 In distribution
TI-600-056 In distribution
TI-600-030 In distribution
TI-1457-010E In distribution
TI-600-044 In distribution
TI-600-090 In distribution
TI-600A-6.4-085 In distribution
TI-600-046 In distribution
TI-600-028 In distribution
TI-600C-10.5-090 In distribution
TI-600-034 In distribution
TI-600-050 In distribution
TI-600C-10.5-070 In distribution
TI-600-052 In distribution
TI-600-048 In distribution
TI-600-036 In distribution
TI-600A-6.4-075 In distribution
TI-600C-10.5-080 In distribution
TI-1457-0S In distribution
TI-600C-10.5-120 In distribution
TI-600A-6.4-070 In distribution
TI-600C-10.5-085 In distribution
TI-600-054 In distribution
TI-600-058 In distribution
TI-600-060 In distribution
TI-600C-10.5-095 In distribution
TI-600C-10.5-100 In distribution
TI-600-065 In distribution
TI-600-038 In distribution
TI-600A-6.4-065 In distribution
TI-600A-6.4-080 In distribution
TI-600A-6.4-090 In distribution
TI-600-070 In distribution
TI-600-042 In distribution
TI-600A-6.4-060 In distribution
TI-600A-6.4-105 In distribution
TI-600C-10.5-115 In distribution
TI-600A-6.4-095 In distribution
TI-600A-6.4-115 In distribution
TI-600A-6.4-110 In distribution
TI-600A-6.4-120 In distribution
TI-600C-10.5-110 In distribution
TI-600C-10.5-075 In distribution
TI-600-032 In distribution
TI-1457-015E In distribution
TI-600C-10.5-105 In distribution
TI-600-085 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
T2 Stryker GmbH 1,373
Autobahn Globus Medical, Inc. 1,258
Gamma Stryker GmbH 1,120
Summa Orthopaedics Femur Nail System Jeil Medical Corporation 742
Arix Femur Nail System Jeil Medical Corporation 742
Orthofix Orthofix SRL 721
Rod, Fixation, Intramedullary And Accessories Synthes Gmbh 715
Trigen Smith & Nephew, Inc. 681
Arthrex® Arthrex, Inc. 665
Precice® Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc. 596
Apex Orthoxel Designated Activity Company 569
Natural Nail® Zimmer, Inc. 552

Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories

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