Hoffmann LRF
HA Coated Blunt Half Pin 15mm Thread
9manufacturers in China registered for this device type
82catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2026-07-15 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 175 to 250 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4938-5-215S | Diameter: 5.0 Millimeter | In distribution |
| 4940-4-115 | Diameter: 4.0 Millimeter | In distribution |
| 4938-6-260S | Length 225.0 mm | In distribution |
| 4940-6-380 | Length 250.0 mm | In distribution |
| 4938-4-140S | Length 175.0 mm | In distribution |
| 4938-6-250S | Length 225.0 mm | In distribution |
| 4940-6-140 | Length 175.0 mm | In distribution |
| 4938-4-115S | Length 175.0 mm | In distribution |
| 4940-6-250 | Diameter: 6.0 Millimeter | In distribution |
| 4938-5-230S | Length 225.0 mm | In distribution |
| 4938-5-225S | Length 225.0 mm | In distribution |
| 4940-5-240 | Diameter: 5.0 Millimeter | In distribution |
| 4938-5-390S | Length 250.0 mm | In distribution |
| 4940-5-235 | Diameter: 5.0 Millimeter | In distribution |
| 4940-6-150 | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-230S | Length 225.0 mm | In distribution |
| 4938-5-260S | Length 225.0 mm | In distribution |
| 4940-6-145 | Length 175.0 mm | In distribution |
| 4938-4-130S | Length 175.0 mm | In distribution |
| 4938-4-150S | Length 175.0 mm | In distribution |
| 4938-6-140S | Diameter: 6.0 Millimeter | In distribution |
| 4938-4-135S | Length 175.0 mm | In distribution |
| 4938-5-250S | Length 225.0 mm | In distribution |
| 4940-4-150 | Diameter: 4.0 Millimeter | In distribution |
| 4938-6-240S | Length 225.0 mm | In distribution |
| 4940-6-170 | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-170S | Length 175.0 mm | In distribution |
| 4940-5-225 | Diameter: 5.0 Millimeter | In distribution |
| 4940-5-250 | Length 225.0 mm | In distribution |
| 4938-6-145S | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-370S | Length 250.0 mm | In distribution |
| 4940-6-245 | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-245S | Diameter: 6.0 Millimeter | In distribution |
| 4938-5-245S | Diameter: 5.0 Millimeter | In distribution |
| 4940-5-380 | Length 250.0 mm | In distribution |
| 4938-4-145S | Diameter: 4.0 Millimeter | In distribution |
| 4940-4-135 | Diameter: 4.0 Millimeter | In distribution |
| 4940-6-260 | Length 225.0 mm | In distribution |
| 4938-5-380S | Length 250.0 mm | In distribution |
| 4940-6-160 | Length 175.0 mm | In distribution |
| 4940-6-240 | Diameter: 6.0 Millimeter | In distribution |
| 4940-4-110 | Diameter: 4.0 Millimeter | In distribution |
| 4940-6-235 | Length 225.0 mm | In distribution |
| 4938-5-235S | Diameter: 5.0 Millimeter | In distribution |
| 4938-6-150S | Length 175.0 mm | In distribution |
| 4940-6-225 | Length 225.0 mm | In distribution |
| 4940-5-245 | Diameter: 5.0 Millimeter | In distribution |
| 4938-5-370S | Length 250.0 mm | In distribution |
| 4940-5-220 | Length 225.0 mm | In distribution |
| 4938-6-125S | Diameter: 6.0 Millimeter | In distribution |
| 4938-5-220S | Diameter: 5.0 Millimeter | In distribution |
| 4940-5-390 | Diameter: 5.0 Millimeter | In distribution |
| 4940-6-130 | Diameter: 6.0 Millimeter | In distribution |
| 4940-6-135 | Length 175.0 mm | In distribution |
| 4938-4-110S | Diameter: 4.0 Millimeter | In distribution |
| 4938-4-120S | Diameter: 4.0 Millimeter | In distribution |
| 4940-5-230 | Length 225.0 mm | In distribution |
| 4940-4-130 | Diameter: 4.0 Millimeter | In distribution |
| 4938-6-135S | Length 175.0 mm | In distribution |
| 4938-6-225S | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-220S | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-160S | Length 175.0 mm | In distribution |
| 4940-5-370 | Length 250.0 mm | In distribution |
| 4940-5-260 | Diameter: 5.0 Millimeter | In distribution |
| 4940-6-390 | Length 250.0 mm | In distribution |
| 4940-6-220 | Length 225.0 mm | In distribution |
| 4938-4-125S | Diameter: 4.0 Millimeter | In distribution |
| 4940-5-215 | Length 225.0 mm | In distribution |
| 4940-6-230 | Diameter: 6.0 Millimeter | In distribution |
| 4940-4-140 | Length 175.0 mm | In distribution |
| 4938-5-240S | Diameter: 5.0 Millimeter | In distribution |
| 4940-4-120 | Length 175.0 mm | In distribution |
| 4940-6-125 | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-390S | Diameter: 6.0 Millimeter | In distribution |
| 4940-4-145 | Length 175.0 mm | In distribution |
| 4940-6-120 | Length 175.0 mm | In distribution |
| 4938-6-380S | Length 250.0 mm | In distribution |
| 4940-6-370 | Diameter: 6.0 Millimeter | In distribution |
| 4940-4-125 | Diameter: 4.0 Millimeter | In distribution |
| 4938-6-130S | Diameter: 6.0 Millimeter | In distribution |
| 4938-6-235S | Length 225.0 mm | In distribution |
| 4938-6-120S | Diameter: 6.0 Millimeter | 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 |
| 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 |
|---|---|
| K211508 | 2021-10-05 |
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.