Tibiaxys®

The 40mm length screw for compression forceps is fixed on the bone through the extremity hole of the compression forceps with reference 219960ND to create a bone compression during the…

Registry build 21.09.26

The 40mm length screw for compression forceps is fixed on the bone through the extremity hole of the compression forceps with reference 219960ND to create a bone compression during the plate fixation.

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

Who Else Makes It

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

Chinese manufacturers registered for FDA product code HWD
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25

Record

Regulatory record for Tibiaxys®
Listed by Newdeal Sas, United States
FDA product code HWD
Device type Starter, Bone Screw
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2017-05-31
Record revised 2023-02-06 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Distribution end date 2027-12-31

Catalogue Numbers

Catalogue numbers for Tibiaxys®
Catalogue number Size Status
159740ND 3.3mm head diameter X 40mm length In distribution
159760ND 3.3mm head diameter X 60mm length In distribution
159755ND 3.3mm head diameter X 55mm length In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Power Dental USA Power Dental U.S.A. Inc. 64
Kompressor™ Compression Screw System Ascension Orthopedics, Inc. 11
Mariner Seaspine Orthopedics Corporation 8
CosmoLock Pedicle Screw System Kalitec Direct, LLC 6
Slimplicity Anterior Cervical Plate System Precision Spine, Inc. 5
Inbone Wright Medical Technology, Inc. 5
Universal2 Total Wrist Implant System Smith & Nephew, Inc. 5
Universal 2™ Total Wrist Implant System Ascension Orthopedics, Inc. 5
Countersink Biomet Orthopedics 5
AMP-LTX Alphatec Spine, Inc. 4
Link Instruments – Fixation instruments Waldemar Link GmbH & Co. KG 3
Power Dental U.S.A., Inc. Power Dental U.S.A. Inc. 3

Showing 12 of 90. All products under Starter, Bone Screw

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