Tap, Bone
TAP FOR 6.5MM Cancellous Bone Screws 197MM/150MM Calibration
12manufacturers in China registered for this device type
191catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWX |
| Device type | Tap, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2025-10-16 (version 6) |
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 |
| Distribution end date | 2025-09-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SD03.614.114 | In distribution | ||
| SD311.919 | In distribution | ||
| 311.400 | In distribution | ||
| 310.95 | In distribution | ||
| 03.614.046 | In distribution | ||
| 03.161.027 | In distribution | ||
| 03.424.124 | In distribution | ||
| 03.620.206 | In distribution | ||
| SD311.300 | In distribution | ||
| 311.035.97S | In distribution | ||
| SD03.632.179 | In distribution | ||
| 311.682 | In distribution | ||
| 311.59 | In distribution | ||
| 311.43 | In distribution | ||
| 311.611 | In distribution | ||
| 03.602.037 | In distribution | ||
| 03.111.908 | In distribution | ||
| 03.420.124 | In distribution | ||
| SD311.613 | In distribution | ||
| 03.535.126 | In distribution | ||
| SD311.619 | In distribution | ||
| 311.605 | In distribution | ||
| 311.31 | In distribution | ||
| 03.616.079 | In distribution | ||
| 03.632.104 | In distribution | ||
| 311.48 | In distribution | ||
| SD311.68 | In distribution | ||
| 311.47 | In distribution | ||
| 03.602.007 | In distribution | ||
| 311.349 | In distribution | ||
| 311.616 | In distribution | ||
| 357.430 | In distribution | ||
| 311.613 | In distribution | ||
| SD03.620.207 | In distribution | ||
| 311.697 | In distribution | ||
| SD311.605 | In distribution | ||
| SD03.630.208 | In distribution | ||
| 311.602 | In distribution | ||
| 03.632.155 | In distribution | ||
| SD311.352 | In distribution | ||
| SD311.622 | In distribution | ||
| SD311.691 | In distribution | ||
| SD311.625 | In distribution | ||
| 311.69 | In distribution | ||
| SD311.433 | In distribution | ||
| SD03.632.105 | In distribution | ||
| SD03.630.209 | In distribution | ||
| SD03.632.365 | In distribution | ||
| 311.46 | In distribution | ||
| SD03.632.180 | In distribution | ||
| 03.620.105 | In distribution | ||
| 311.696 | In distribution | ||
| 311.39 | In distribution | ||
| SD03.630.206 | In distribution | ||
| 311.63 | In distribution | ||
| 311.431 | In distribution | ||
| 03.620.104 | In distribution | ||
| 311.66 | In distribution | ||
| SD311.611 | In distribution | ||
| 311.55 | In distribution | ||
| SD03.630.205 | In distribution | ||
| SD387.279 | In distribution | ||
| 03.602.005 | In distribution | ||
| 03.620.225 | In distribution | ||
| 03.161.026 | In distribution | ||
| SD03.632.107 | In distribution | ||
| 03.620.209 | In distribution | ||
| SD311.353 | In distribution | ||
| 03.614.053 | In distribution | ||
| SD03.630.207 | In distribution | ||
| SD311.007 | In distribution | ||
| SD311.624 | In distribution | ||
| 03.602.036 | In distribution | ||
| SD311.349 | In distribution | ||
| 03.620.207 | In distribution | ||
| SD311.614 | In distribution | ||
| SD311.351 | In distribution | ||
| SD03.632.177 | In distribution | ||
| 03.602.035 | In distribution | ||
| 311.404 | In distribution | ||
| 03.620.208 | In distribution | ||
| 311.34 | In distribution | ||
| SD311.603 | In distribution | ||
| 03.620.229 | In distribution | ||
| 03.620.205 | In distribution | ||
| SD311.602 | In distribution | ||
| 03.632.105 | In distribution | ||
| 03.616.076 | In distribution | ||
| SD311.380 | In distribution | ||
| 03.620.226 | In distribution | ||
| 311.694 | In distribution | ||
| SD311.626 | In distribution | ||
| 03.602.016 | In distribution | ||
| 03.632.107 | In distribution | ||
| 311.32 | In distribution | ||
| 311.01.98 | In distribution | ||
| SD311.623 | In distribution | ||
| 311.689 | In distribution | ||
| SD311.918 | In distribution | ||
| 311.01 | In distribution | ||
| SD311.609 | In distribution | ||
| 388.287 | In distribution | ||
| 311.604 | In distribution | ||
| SD311.354 | In distribution | ||
| 03.616.075 | In distribution | ||
| 03.010.496 | In distribution | ||
| 328.140 | In distribution | ||
| SD311.004 | In distribution | ||
| 311.26 | In distribution | ||
| 389.477 | In distribution | ||
| 311.612 | In distribution | ||
| 03.527.124 | In distribution | ||
| SD03.632.106 | In distribution | ||
| 388.285 | In distribution | ||
| SD03.010.080 | In distribution | ||
| 03.010.080 | In distribution | ||
| SD311.005 | In distribution | ||
| SD03.632.375 | In distribution | ||
| SD03.632.182 | In distribution | ||
| SD311.006 | In distribution | ||
| SD311.621 | In distribution | ||
| 03.010.516 | In distribution | ||
| 03.616.077 | In distribution | ||
| 311.606 | In distribution | ||
| 389.812 | In distribution | ||
| SD311.618 | In distribution | ||
| SD03.614.113 | In distribution | ||
| SD03.632.181 | In distribution | ||
| 388.288 | In distribution | ||
| 311.692 | In distribution | ||
| 311.402 | In distribution | ||
| SD03.620.205 | In distribution | ||
| 387.276 | In distribution | ||
| 311.603 | In distribution | ||
| SD311.612 | In distribution | ||
| U44-640-14-02S | 2 | In distribution | |
| 03.614.045 | In distribution | ||
| SD311.615 | In distribution | ||
| 03.620.228 | In distribution | ||
| SD311.350 | In distribution | ||
| 03.630.908 | In distribution | ||
| SD311.003 | In distribution | ||
| SD03.010.001 | In distribution | ||
| 311.33 | In distribution | ||
| 325.12 | In distribution | ||
| 03.226.040 | In distribution | ||
| 388.284 | In distribution | ||
| 311.698 | In distribution | ||
| 311.44 | In distribution | ||
| 388.289 | In distribution | ||
| SD311.604 | In distribution | ||
| SD03.632.385 | In distribution | ||
| 311.615 | In distribution | ||
| 03.616.078 | In distribution | ||
| SD311.620 | In distribution | ||
| SD03.630.255 | In distribution | ||
| SD03.632.176 | In distribution | ||
| SD03.632.345 | In distribution | ||
| 03.620.106 | In distribution | ||
| 387.277 | In distribution | ||
| 03.527.126 | In distribution | ||
| SD03.620.206 | In distribution | ||
| 03.620.227 | In distribution | ||
| 03.632.109 | In distribution | ||
| 03.614.052 | In distribution | ||
| SD311.610 | In distribution | ||
| 03.602.006 | In distribution | ||
| 311.01.96 | In distribution | ||
| 03.632.103 | In distribution | ||
| 03.424.126 | In distribution | ||
| 388.286 | In distribution | ||
| 311.28 | In distribution | ||
| 03.602.034 | In distribution | ||
| SD03.010.002 | In distribution | ||
| 311.056.97S | In distribution | ||
| 311.601 | In distribution | ||
| 311.693 | In distribution | ||
| 03.535.128 | In distribution | ||
| SD311.69 | In distribution | ||
| 03.614.015 | In distribution | ||
| SD03.632.155 | In distribution | ||
| 03.630.907 | In distribution | ||
| SD311.627 | In distribution | ||
| SD311.440 | In distribution | ||
| 03.602.004 | In distribution | ||
| 311.614 | In distribution | ||
| SD03.632.178 | In distribution | ||
| 03.632.106 | In distribution | ||
| 03.632.108 | In distribution | ||
| 387.61 | Withdrawn | ||
| 325.14 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 429 |
| Mariner | Seaspine Orthopedics Corporation | 285 |
| Tap, Bone | Depuy Spine, Inc. | 248 |
| Tap, Bone | Medtronic Sofamor Danek, Inc. | 228 |
| Invictus | Alphatec Spine, Inc. | 129 |
| Specials | Seaspine Orthopedics Corporation | 99 |
| Arsenal | Alphatec Spine, Inc. | 82 |
| Generic Surgical Instruments | CTL Medical Corporation | 81 |
| Mariner MIS | Seaspine Orthopedics Corporation | 78 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 72 |
| Custom | Medicrea International | 68 |
| Anax 5.5™ Spinal System | CG MedTech Co., Ltd. | 65 |
Showing 12 of 545. All products under Tap, Bone
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | UDI-DI | 2026-02-25 | Class II | Process change control | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. | 77 units |
| Synthes (USA) Products LLC | UDI-DI | 2026-02-25 | Class II | Process change control | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. | 33 units |
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.