Z-Staple

Z-Staple Mini Spikes 12 / 10mm 26°

Registry build 21.09.26
7manufacturers in China registered for this device type
34catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDR
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Kingj Medical Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7
Hangzhou Sino-MIM Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 6
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38

Record

Regulatory record for Z-Staple
Listed by Z-Medical Gmbh & Co. KG, Germany
FDA product code JDR
Device type Staple, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3030
Establishment Repacker / relabeller, Manufacturer, Exporter
Record published 2016-06-30
Record revised 2021-11-23 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Z-Staple
Catalogue number Size Status
C03 252 In distribution
C03 009 In distribution
C03 260 In distribution
C03 208 In distribution
C03 142 In distribution
C03 002 In distribution
C03 250 In distribution
C03 261 In distribution
C03 001 In distribution
C03 263 In distribution
C03 207 In distribution
C03 130 In distribution
C03 154 In distribution
C03 206 In distribution
C03 141 In distribution
C03 140 In distribution
C03 011 In distribution
C03 156 In distribution
C03 003 In distribution
C03 013 In distribution
C03 209 In distribution
C03 153 In distribution
C03 004 In distribution
C03 205 In distribution
C03 155 In distribution
C03 132 In distribution
C03 133 In distribution
C03 010 In distribution
C03 131 In distribution
C03 262 In distribution
C03 210 In distribution
C03 251 In distribution
C03 152 In distribution
C03 211 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DynaBridge Fusion Orthopedics, LLC 156
Arthrex® Arthrex, Inc. 80
Staple, Fixation, Bone Smith & Nephew, Inc. 59
Compression Staple System Tornier Inc. 36
UNI-Clip Newdeal Sas 35
Orbitum Staple System CPM Medical Consultants, LLC. 32
OSStaple Biomedical Enterprises, Inc. 30
Acumed Acumed LLC 30
Stealthfix Intraosseous Fixation System Medartis Inc. 29
Staple, Fixation, Bone Stryker GmbH 29
Step Boss Biomedical Enterprises, Inc. 27
Fuseforce Wright Medical Technology, Inc. 26

Showing 12 of 319. All products under Staple, Fixation, 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