A.l.p.s.®

67 catalogue numbers from 8562-45-210, listed by Biomet Orthopedics, United States, under Washer, Bolt Nut. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26
9manufacturers in China registered for this device type
67catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTN
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
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
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Suzhou Endophix Co., Ltd. Suzhou Jiangsu Manufacturer 17

Record

Regulatory record for A.l.p.s.®
Listed by Biomet Orthopedics, United States
FDA product code HTN
Device type Washer, Bolt Nut
Device class Class 2
Regulation 21 CFR 888.3030
510(k) K101421
Record published 2020-07-13
Record revised 2025-11-20 (version 7)

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

Catalogue Numbers

Catalogue numbers for A.l.p.s.®
Catalogue number Size Status
8562-45-210 10 HOLE In distribution
1312-18-200 Small 7 Hole 64 mm In distribution
1512-20-310 1.3 MM x 10 MM In distribution
8513-18-800 21 HOLE RIGHT 210 MM In distribution
8563-35-048 3.5 mm x 48 mm In distribution
8561-35-052 3.5 mm x 52 mm In distribution
8563-27-038 2.7 MM x 38 MM In distribution
110018026 3.5 mm x 26 mm In distribution
110018038 3.5 mm x 38 mm In distribution
8162-04-007 7H In distribution
110018032 3.5 mm x 32 mm In distribution
8563-27-014 2.7 MM x 14 MM In distribution
8561-35-048 3.5 mm x 48 mm In distribution
8562-45-005 5 HOLE In distribution
8562-06-003 3 HOLE In distribution
8513-18-601 13 HOLE 104 MM In distribution
8162-04-012 12H In distribution
1512-20-412 1.5 MM x 12 MM In distribution
8561-40-060 4.0 mm x 60 mm In distribution
8562-04-010 10 HOLE In distribution
8561-45-252 4.5 MM x 52 MM In distribution
8561-35-038 3.5 mm x 38 mm In distribution
8562-04-006 6 HOLE In distribution
8162-06-010 10H In distribution
8513-18-207 11 HOLE LEFT 103 MM In distribution
8561-40-042 4.0 mm x 42 mm In distribution
8562-06-008 8 HOLE In distribution
8550-37-010 3.5 MM x 10 MM In distribution
8550-37-034 3.5 MM x 34 MM In distribution
8561-45-220 4.5 MM x 20 MM In distribution
110017750 3.5 mm x 50 mm In distribution
8513-18-703 10 HOLE LEFT 97 MM In distribution
8513-18-707 13 HOLE LEFT 127 MM In distribution
8513-18-708 17 HOLE LEFT 166 MM In distribution
110018042 3.5 mm x 42 mm In distribution
110018034 3.5 mm x 34 mm In distribution
110018058 3.5 mm x 58 mm In distribution
8562-35-012 12 HOLE In distribution
1512-20-312 1.3 MM x 12 MM In distribution
8162-04-014 14H In distribution
110017740 3.5 mm x 40 mm In distribution
110018060 3.5 mm x 60 mm In distribution
8513-18-803 21 HOLE LEFT 210 MM In distribution
1512-20-309 1.3 MM x 9 MM In distribution
8561-40-048 4.0 mm x 48 mm In distribution
1312-18-703 Large 10 Hole 97 mm In distribution
1512-20-314 1.3 MM x 14 MM In distribution
8162-35-509 9 HOLE In distribution
110017724 3.5 mm x 24 mm In distribution
1512-20-252 2.5 MM In distribution
8562-45-208 8 HOLE In distribution
8513-18-609 21 HOLE 194 MM In distribution
110018030 3.5 mm x 30 mm In distribution
8162-35-513 13 HOLE In distribution
8561-45-214 4.5 MM x 14 MM In distribution
8550-37-046 3.5 MM x 46 MM In distribution
1512-20-155 1.5 MM In distribution
110018052 3.5 mm x 52 mm In distribution
8562-02-006 6 HOLE In distribution
8550-37-026 3.5 MM x 26 MM In distribution
110018024 3.5 mm x 24 mm In distribution
8512-35-042 3.5 mm x 42 mm In distribution
8561-55-065 5.5 MM x 65 MM In distribution
110018046 3.5 mm x 46 mm In distribution
1512-20-514 1.5 MM x 14 MM In distribution
8513-18-205 15 HOLE RIGHT 142 MM In distribution
8550-37-040 3.5 MM x 40 MM In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Washer, Bolt Nut Zimmer, Inc. 308
MaxTorque™ Tornier Inc. 171
Arthrex® Arthrex, Inc. 154
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 92
Washer, Bolt Nut Synthes Gmbh 88
Variax Stryker GmbH 59
Conmed ConMed Corporation 38
Neoortho Neoortho Produtos Ortopédicos S/A 32
Aptus Medartis Inc. 31
AC Device Lockdown Medical Limited 31
Evos Smith & Nephew, Inc. 28
Axis Extremity Medical, LLC 26

Showing 12 of 304. All products under Washer, Bolt Nut

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