Tap, Bone
TAP Cannulated FOR 4.0MM Cannulated Screws
12manufacturers in China registered for this device type
18catalogue numbers in this listing
1recall
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 | Sterilmed, Inc., United States |
|---|---|
| FDA product code | HWX |
| Device type | Tap, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-18 |
| Record revised | 2025-07-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-06-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STR5018-5-120 | Withdrawn | |
| RIC71173318 | Withdrawn | |
| ZIM2346-46 | Withdrawn | |
| SYN311.31 | Withdrawn | |
| SYN311.32 | Withdrawn | |
| ZIM2346-47 | Withdrawn | |
| ZIM4811-110-35 | Withdrawn | |
| DEP8241-62-000 | Withdrawn | |
| SYN311.190 | Withdrawn | |
| SYN311.48 | Withdrawn | |
| SYN311.33 | Withdrawn | |
| SYN311.26 | Withdrawn | |
| SYN314.467 | Withdrawn | |
| SYN311.63 | Withdrawn | |
| SYN311.46 | Withdrawn | |
| SYN311.34 | Withdrawn | |
| SYN311.39 | Withdrawn | |
| SYN311.59 | 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 |
| Tap, Bone | Synthes Gmbh | 191 |
| 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 |
Showing 12 of 545. All products under Tap, Bone
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-08-08 | Not classified | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on o | 4 | 2011-04-26 |
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.