Buxton BioMedical

Dahmen Osteotome, angled, 12mm

Registry build 21.09.26
9manufacturers in China registered for this device type
61catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code HWM
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31

Record

Regulatory record for Buxton BioMedical
Listed by Buxton Biomedical, Inc., United States
FDA product code HWM
Device type Osteotome
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2025-11-03
Record revised 2024-09-02 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Distribution end date 2024-08-20

Catalogue Numbers

Catalogue numbers for Buxton BioMedical
Catalogue number Size Status
77-1512 In distribution
56-7204 In distribution
56-7195 In distribution
24-4291 In distribution
77-1110 In distribution
77-1104 In distribution
56-7312 In distribution
56-7206 In distribution
24-4200 In distribution
77-1105 In distribution
77-1504 In distribution
24-4210 In distribution
77-1122 In distribution
77-7115 In distribution
56-7115 In distribution
24-4299 In distribution
77-1125 In distribution
56-7102 In distribution
56-7104 In distribution
56-7132 In distribution
24-4201 In distribution
77-7108 In distribution
24-4315 In distribution
77-1120 In distribution
56-7306 In distribution
77-1515 In distribution
77-7118 In distribution
77-7113 In distribution
77-1112 In distribution
56-7310 In distribution
77-1510 In distribution
24-4216 In distribution
77-1522 In distribution
77-7130 In distribution
77-4007 In distribution
77-4025 In distribution
77-1115 In distribution
56-7128 In distribution
77-7125 In distribution
56-7103 In distribution
77-7110 In distribution
56-7308 In distribution
77-1520 In distribution
56-7106 In distribution
77-4030 In distribution
56-7315 In distribution
56-7130 In distribution
56-7108 In distribution
24-4225 In distribution
77-1525 In distribution
56-7124 In distribution
77-1106 In distribution
56-7208 In distribution
56-7210 In distribution
77-7120 In distribution
56-7112 In distribution
24-4205 In distribution
77-1108 In distribution
77-4015 In distribution
56-7110 In distribution
77-1120 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 300
Life Instruments Life Instrument Corp. 283
Osteotome KLS-Martin L.P. 262
Boss Instruments Boss Instruments, Ltd. 249
MSI Precision Specialty Instruments MED Saver, Inc. 243
Innomed, Inc. Innomed, Inc. 241
Ambler Surgical Ambler Surgical, LLC 226
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 225
Novo Surgical Novo Surgical, Inc. 213
Novo Surgical Inc. Novo Surgical, Inc. 177
Osteotome Biomet Microfixation 170
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 158

Showing 12 of 279. All products under Osteotome

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