A.l.p.s.®
55 catalogue numbers from 8561-45-254, listed by Biomet Orthopedics, United States, under Pin, Fixation, Threaded. 9 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Record published | 2020-09-04 |
| Record revised | 2025-05-30 (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 |
|---|---|---|
| 8561-45-254 | 4.5 MM x 54 MM | In distribution |
| 8162-35-609 | 9 HOLE | In distribution |
| 8562-03-009 | 9 HOLE | In distribution |
| 8561-35-056 | 3.5 mm x 56 mm | In distribution |
| 8513-18-202 | 7 HOLE LEFT 64 MM | In distribution |
| 8562-04-012 | 12 HOLE | In distribution |
| 8550-37-038 | 3.5 MM x 38 MM | In distribution |
| 8562-02-012 | 12 HOLE | In distribution |
| 8561-55-080 | 5.5 MM x 80 MM | In distribution |
| 8562-01-009 | 9 HOLE | In distribution |
| 8561-45-258 | 4.5 MM x 58 MM | In distribution |
| 1512-20-413 | 1.5 MM x 13 MM | In distribution |
| 8562-35-006 | 6 HOLE | In distribution |
| 8162-35-607 | 7 HOLE | In distribution |
| 8561-35-010 | 3.5 mm x 10 mm | In distribution |
| 8561-35-014 | 3.5 mm x 14 mm | In distribution |
| 8563-35-040 | 3.5 mm x 40 mm | In distribution |
| 8561-45-242 | 4.5 MM x 42 MM | In distribution |
| 8513-18-203 | 9 HOLE LEFT 85 MM | In distribution |
| 8562-35-005 | 5 HOLE | In distribution |
| 8162-04-008 | 8H | In distribution |
| 8562-03-006 | 6 HOLE | In distribution |
| 1512-20-418 | 1.5 MM x 18 MM | In distribution |
| 8562-07-008 | 8 HOLE | In distribution |
| 8563-35-020 | 3.5 mm x 20 mm | In distribution |
| 1512-20-520 | 1.5 MM x 20 MM | In distribution |
| 8561-45-248 | 4.5 MM x 48 MM | In distribution |
| 8563-35-052 | 3.5 mm x 52 mm | In distribution |
| 8513-18-700 | 9 HOLE RIGHT 88 MM | In distribution |
| 8561-35-050 | 3.5 mm x 50 mm | In distribution |
| 8563-27-046 | 2.7 MM x 46 MM | In distribution |
| 8562-11-012 | 12 HOLE | In distribution |
| 8550-37-065 | 3.5 MM x 65 MM | In distribution |
| 8561-45-224 | 4.5 MM x 24 MM | In distribution |
| 8563-35-022 | 3.5 mm x 22 mm | In distribution |
| 8563-27-036 | 2.7 MM x 36 MM | In distribution |
| 8563-35-012 | 3.5 mm x 12 mm | In distribution |
| 1512-20-411 | 1.5 MM x 11 MM | In distribution |
| 1512-20-308 | 1.3 MM x 8 MM | In distribution |
| 8562-10-012 | 12 HOLE | In distribution |
| 8512-35-050 | 3.5 mm x 50 mm | In distribution |
| 8561-55-026 | 5.5 MM x 26 MM | In distribution |
| 8561-40-065 | 4.0 mm x 65 mm | In distribution |
| 8561-55-048 | 5.5 MM x 48 MM | In distribution |
| 8562-45-012 | 12 HOLE | In distribution |
| 8162-35-603 | 3 HOLE | In distribution |
| 8561-45-246 | 4.5 MM x 46 MM | In distribution |
| 8561-40-044 | 4.0 mm x 44 mm | In distribution |
| 8550-37-020 | 3.5 MM x 20 MM | In distribution |
| 1312-18-702 | Small 9 Hole 88 mm | In distribution |
| 8562-11-009 | 9 HOLE | In distribution |
| 8562-45-206 | 6 HOLE | In distribution |
| 8562-35-009 | 9 HOLE | In distribution |
| 1312-18-201 | Large 9 Hole 85 mm | In distribution |
| 1512-20-152 | 1.5 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
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.