PIN Screw
Cancellous Pin Screw, 5mm Shaft Diameter x 5mm Thread Diameter x 130mm Total Length x 50mm Thread Length
9manufacturers in China registered for this device type
118catalogue numbers in this listing
1510(k) clearance
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 | BK Meditech Co., Ltd., South Korea |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K061599 |
| Record published | 2015-09-22 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31930-30-15 | In distribution | |
| 31745-40-08 | In distribution | |
| 31920-15-10 | In distribution | |
| 31760-60-13 | In distribution | |
| 31736-20-07 | In distribution | |
| 31920-30-12 | In distribution | |
| 31750-50-12 | In distribution | |
| 31734-20-07 | In distribution | |
| 31916-15-10 | In distribution | |
| 31740-30-10 | In distribution | |
| 31760-40-12 | In distribution | |
| 31850-50-13 | In distribution | |
| 31724-20-07 | In distribution | |
| 31860-50-11 | In distribution | |
| 31750-30-15 | In distribution | |
| 31860-60-14 | In distribution | |
| 31920-20-12 | In distribution | |
| 31923-40-15 | In distribution | |
| 31930-40-15 | In distribution | |
| 31730-20-07 | In distribution | |
| 31760-50-12 | In distribution | |
| 31923-20-15 | In distribution | |
| 31750-50-18 | In distribution | |
| 31723-15-04 | In distribution | |
| 31760-40-18 | In distribution | |
| 31860-60-16 | In distribution | |
| 31850-50-15 | In distribution | |
| 31750-30-18 | In distribution | |
| 31760-40-13 | In distribution | |
| 31760-50-18 | In distribution | |
| 31923-30-15 | In distribution | |
| 31740-40-08 | In distribution | |
| 31760-30-18 | In distribution | |
| 31745-30-12 | In distribution | |
| 31760-40-15 | In distribution | |
| 31736-30-08 | In distribution | |
| 31750-20-12 | In distribution | |
| 31860-70-18 | In distribution | |
| 31860-50-15 | In distribution | |
| 31730-25-07 | In distribution | |
| 31923-35-15 | In distribution | |
| 31750-50-15 | In distribution | |
| 31760-20-12 | In distribution | |
| 31930-35-15 | In distribution | |
| 31930-15-10 | In distribution | |
| 31750-40-12 | In distribution | |
| 31740-40-15 | In distribution | |
| 31850-60-18 | In distribution | |
| 31860-40-12 | In distribution | |
| 31916-15-06 | In distribution | |
| 31850-50-17 | In distribution | |
| 31760-20-15 | In distribution | |
| 31760-60-18 | In distribution | |
| 31923-25-15 | In distribution | |
| 31750-40-18 | In distribution | |
| 31850-60-15 | In distribution | |
| 31916-20-10 | In distribution | |
| 31850-70-18 | In distribution | |
| 31750-40-17 | In distribution | |
| 31860-80-17 | In distribution | |
| 31860-50-13 | In distribution | |
| 31760-60-15 | In distribution | |
| 31740-30-12 | In distribution | |
| 31760-30-12 | In distribution | |
| 31736-20-06 | In distribution | |
| 31920-15-06 | In distribution | |
| 31860-50-12 | In distribution | |
| 31930-15-06 | In distribution | |
| 31760-30-15 | In distribution | |
| 31860-30-18 | In distribution | |
| 31920-25-12 | In distribution | |
| 31745-40-12 | In distribution | |
| 31923-15-10 | In distribution | |
| 31745-40-15 | In distribution | |
| 31740-40-12 | In distribution | |
| 31740-30-08 | In distribution | |
| 31745-30-10 | In distribution | |
| 31730-30-07 | In distribution | |
| 31860-60-15 | In distribution | |
| 31730-25-06 | In distribution | |
| 31745-20-06 | In distribution | |
| 31860-40-18 | In distribution | |
| 31860-30-15 | In distribution | |
| 31760-50-16 | In distribution | |
| 31724-13-07 | In distribution | |
| 31860-60-18 | In distribution | |
| 31860-30-12 | In distribution | |
| 31930-13-10 | In distribution | |
| 31920-35-12 | In distribution | |
| 31760-50-15 | In distribution | |
| 31930-45-15 | In distribution | |
| 31930-13-06 | In distribution | |
| 31930-20-15 | In distribution | |
| 31730-20-05 | In distribution | |
| 31750-30-12 | In distribution | |
| 31860-70-16 | In distribution | |
| 31750-20-15 | In distribution | |
| 31923-15-06 | In distribution | |
| 31916-25-10 | In distribution | |
| 31860-40-15 | In distribution | |
| 31860-50-18 | In distribution | |
| 31760-50-14 | In distribution | |
| 31734-35-08 | In distribution | |
| 31860-40-13 | In distribution | |
| 31745-30-07 | In distribution | |
| 31730-30-06 | In distribution | |
| 31736-40-09 | In distribution | |
| 31750-40-15 | In distribution | |
| 31860-50-14 | In distribution | |
| 31860-80-20 | In distribution | |
| 31930-25-15 | In distribution | |
| 31850-50-18 | In distribution | |
| 31740-20-07 | In distribution | |
| 31760-30-11 | In distribution | |
| 31730-20-06 | In distribution | |
| 31723-20-05 | In distribution | |
| 31760-60-16 | In distribution | |
| 31860-60-13 | 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 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
| gSource | Gsource, LLC. | 74 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061599 | 2006-07-26 |
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.