Hook, Bone

The Femur Hook and Rail Package is used on STERIS Surgical Tables to assist during orthopedic procedures.

Registry build 21.09.26
3manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Beijing (1).

Chinese manufacturers registered for FDA product code KIK
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31

Record

Regulatory record for Hook, Bone
Listed by Steris Corporation, United States
FDA product code KIK
Device type Hook, Bone
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-04-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries manufacturing date

Catalogue Numbers

Catalogue numbers for Hook, Bone
Catalogue number Size Status
Femur Hook In distribution
BF876 In distribution
Femur Hook In distribution
Femur Hook In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HNM Medical HNM Stainless, LLC. 65
Millennium Avalign Technologies, Inc. 34
Innomed, Inc. Innomed, Inc. 18
gSource Gsource, LLC. 18
Avalign Avalign Technologies, Inc. 14
General Instrument Orthopediatrics, Corp 13
Boss Instruments Boss Instruments, Ltd. 13
Orthomed Ortho-MED, Inc. 13
Ambler Surgical Ambler Surgical, LLC 12
Novo Surgical Inc. Novo Surgical, Inc. 10
Novo Surgical Novo Surgical, Inc. 9
Kmedic Teleflex Medical LLC 8

Showing 12 of 54. All products under Hook, 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