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.
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.
| 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
| 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
| 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 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
| 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.