Alliant Biotech

Low Profile Cable System

Registry build 21.09.26
5manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDQ
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38

Record

Regulatory record for Alliant Biotech
Listed by Medisurge, LLC, United States
FDA product code JDQ
Device type Cerclage, Fixation
Device class Class 2
Regulation 21 CFR 888.3010
510(k) K951844
Record published 2024-08-02

Specifications

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

Catalogue Numbers

Catalogue numbers for Alliant Biotech
Catalogue number Size Status
BIO-1-1012 In distribution
BIO-1-1012-A In distribution
BIO-1-1007 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cerclage, Fixation Synthes Gmbh 102
Optilink Synthes Gmbh 61
Songer® Spinal Cable System Pioneer Surgical Technology, Inc. 60
DePuy Songer Spinal Cable System Pioneer Surgical Technology, Inc. 36
Tritium® Sternal Cable Plate System Pioneer Surgical Technology, Inc. 34
Dall-Miles Howmedica Osteonics Corp 22
Sternal Cable System Pioneer Surgical Technology, Inc. 20
Sternal Cable System A & E Medical Corporation 19
Compression Screw System Biomet Orthopedics 18
Accord Smith & Nephew, Inc. 15
Cable-Ready® Zimmer, Inc. 14
Arthrex® Arthrex, Inc. 10

Showing 12 of 56. All products under Cerclage, Fixation

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