SM K-Wires

BMA-S90002 SM K-WIRE.045" (1.1MM)

Registry build 21.09.26
12manufacturers in China registered for this device type
75catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTY
Manufacturer City Province Registered as Device types
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
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Kingj Medical Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7
Aplus (Guangzhou) Medical Technology Company Guangzhou Guangdong Contract manufacturer 6
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38

Record

Regulatory record for SM K-Wires
Listed by Peter Brasseler Holdings, LLC
FDA product code HTY
Device type Pin, Fixation, Smooth
Device class Class 2
Regulation 21 CFR 888.3040
Record published 2022-12-01
Record revised 2025-11-25 (version 8)

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, manufacturing date
Distribution end date 2022-10-20

Catalogue Numbers

Catalogue numbers for SM K-Wires
Catalogue number Size Status
5014799M1 In distribution
5004204M2 In distribution
5004145M2 In distribution
5004205M2 In distribution
5004158M2 In distribution
5004161M2 In distribution
5004149M2 In distribution
5004142M2 In distribution
5004190M2 In distribution
5004207M2 In distribution
5004182M2 In distribution
5004148M2 In distribution
5004192M2 In distribution
5004151M3 In distribution
5004150M2 In distribution
5004193M2 In distribution
5004162M2 In distribution
5004174M2 In distribution
5004173M2 In distribution
5004198M2 In distribution
5004189M2 In distribution
5014797M1 In distribution
5004143M2 In distribution
5004206M2 In distribution
5004196M2 In distribution
5004181M2 In distribution
5004152M2 In distribution
5004187M2 In distribution
5025836M0 In distribution
5004179M2 In distribution
5008001M2 In distribution
5004159M2 In distribution
5004168M2 In distribution
5004200M2 In distribution
5004167M2 In distribution
5014798M1 In distribution
5004197M2 In distribution
5004160M2 In distribution
5004183M2 In distribution
5004170M2 In distribution
5004166M2 In distribution
5014800M1 In distribution
5004186M2 In distribution
5004169M2 In distribution
5025819M0 In distribution
5004156M2 In distribution
5004157M2 In distribution
5004172M2 In distribution
5004144M2 In distribution
5004188M2 In distribution
5004177M2 In distribution
5004146M2 In distribution
5004163M2 In distribution
5004175M2 In distribution
5004178M2 In distribution
5004209M2 In distribution
5004164M2 In distribution
5004202M2 In distribution
5004155M2 In distribution
5004203M2 In distribution
5004210M2 In distribution
5004180M2 In distribution
5004191M2 In distribution
5004184M2 In distribution
5004176M2 In distribution
5004194M2 In distribution
5004208M2 In distribution
5004201M2 In distribution
5004165M2 In distribution
5004195M2 In distribution
5014797M0 Withdrawn
5014798M0 Withdrawn
5014791M0 Withdrawn
5014799M0 Withdrawn
5014800M0 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rondo’ Citieffe SRL 265
HNM Medical HNM Stainless, LLC. 232
Kmedic Teleflex Medical LLC 227
gSource Gsource, LLC. 221
MicroAire® Microaire Surgical Instruments LLC 213
Orthomed Ortho-MED, Inc. 163
mahe medical GmbH Mahe Intl., Inc. 160
Pin, Fixation, Smooth Key Surgical, LLC 134
Pin, Fixation, Smooth Stryker GmbH 134
Aptus Medartis Inc. 134
Key Surgical K-Wires and Steinmann Pins Key Surgical, LLC 126
PedFlex Flexible Nailing System Orthopediatrics, Corp 119

Showing 12 of 682. All products under Pin, Fixation, Smooth

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