Tap, Bone
Instrument 8670085 4.5MM 5.5MM SLF DG TP
12manufacturers in China registered for this device type
228catalogue 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HWX |
| Device type | Tap, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2024-11-04 |
| Record revised | 2022-09-16 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-11-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8670065 | In distribution | |
| EX0215088 | 4.5mm | In distribution |
| 836-015 | DIA=5.5mm | In distribution |
| X0615098 | 5.5mm | In distribution |
| 5484885 | D=4.5mm-5.5mm | In distribution |
| X0810714 | 7.0mm | In distribution |
| 8350382 | In distribution | |
| 902-341 | 18mm | In distribution |
| 8670085 | In distribution | |
| X1010055 | 9.0mm | In distribution |
| EX1016103 | 7.5mm | In distribution |
| 8230920 | In distribution | |
| EX1115035 | 4.5mm | In distribution |
| EX0211170 | 6.5mm | In distribution |
| X0615095 | 4.0mm | In distribution |
| EX0516074 | 6.0mm | In distribution |
| EX0211167 | 5.0mm | In distribution |
| EX1016032 | 12mm | In distribution |
| EX1016098 | 4.5mm | In distribution |
| 8670085 | In distribution | |
| 8670045 | In distribution | |
| 8670055 | 5.5mm | In distribution |
| EX0211174 | 8.5mm | In distribution |
| X0315092 | 6.5mm | In distribution |
| X0615094 | 3.75mm | In distribution |
| EX1216060 | 5.5mm | In distribution |
| EX0217020 | 3.0mm | In distribution |
| EX0211172 | 7.5mm | In distribution |
| 3030035 | 3.5mm | In distribution |
| EX0516080 | 9.0mm | In distribution |
| 7756035 | 3.5mm | In distribution |
| 7756045 | 4.5mm | In distribution |
| EX1016100 | 5.5mm | In distribution |
| 815-516 | 5mm | In distribution |
| EX0914104 | In distribution | |
| 5484845 | D=4.5mm | In distribution |
| 7756383 | 4.5mm | In distribution |
| EX1016101 | 6.0mm | In distribution |
| EX0116031 | 6.5mm | In distribution |
| EX0116030 | 5.5mm | In distribution |
| X0810717 | 8.5mm | In distribution |
| X0810713 | 6.5mm | In distribution |
| 7080920 | In distribution | |
| 3606040 | 4.0mm | In distribution |
| 5484855 | D=5.5mm | In distribution |
| X0811297 | 10.0mm | In distribution |
| 902-241 | 16MM | In distribution |
| X0810711 | 5.5mm | In distribution |
| EX0516077 | 7.5mm | In distribution |
| X0894-020 | 6.5mm | In distribution |
| EX1016097 | 4.0mm | In distribution |
| 8350381 | In distribution | |
| EX0516075 | 6.5mm | In distribution |
| 8350383 | In distribution | |
| EX0215119 | 7.5mm | In distribution |
| X0315088 | 4.5mm | In distribution |
| EX0114041 | 9.0mm | In distribution |
| 902-441 | 20mm | In distribution |
| EX0217071 | 4.0mm | In distribution |
| 836-014 | DIA=4.5mm | In distribution |
| 836-018 | DIA=7.5mm | In distribution |
| X0315087 | 4.5mm | In distribution |
| X0810719 | 9.5mm | In distribution |
| EX0516072 | 5.0mm | In distribution |
| 8350382 | 6.5mm | In distribution |
| EX0316041 | D=5.5mm-6.5mm | In distribution |
| EX0516076 | 7.0mm | In distribution |
| 3606030 | 3.0mm | In distribution |
| EX0914103 | In distribution | |
| 900-442 | 14mm | In distribution |
| X0811298 | 10.5mm | In distribution |
| 8230924 | In distribution | |
| 7756300 | 3.0mm | In distribution |
| 876-474 | 4.0mm | In distribution |
| EX0211166 | 4.5mm | In distribution |
| X0615096 | 4.5mm | In distribution |
| 3600500 | 5.0mm | In distribution |
| X0514006 | DIA=5.5mm | In distribution |
| 8231333 | 7.5mm | In distribution |
| 9870060 | In distribution | |
| EX0316054 | 4.5mm | In distribution |
| EX1016099 | 5.0mm | In distribution |
| X0315091 | 6.0mm | In distribution |
| EX0211169 | 6.0mm | In distribution |
| X0911001 | 3.0mm | In distribution |
| 8350301 | In distribution | |
| 8784500 | In distribution | |
| EX0816082 | 5.5mm | In distribution |
| EX0516073 | 5.5mm | In distribution |
| 8350426 | 6.5mm | In distribution |
| X0315093 | 7.5mm | In distribution |
| 3602102 | In distribution | |
| 8785500 | In distribution | |
| 8350298 | In distribution | |
| EX1216059 | 4.5mm | In distribution |
| 8684500 | DIA=4.5mm | In distribution |
| 8670055 | In distribution | |
| 8670075 | 7.5mm | In distribution |
| X0810715 | 7.5mm | In distribution |
| 3600501 | 5.0mm | In distribution |
| 8670065 | 6.5mm | In distribution |
| 7756334 | 4.5mm | In distribution |
| 900-842 | 18mm | In distribution |
| EX0211173 | 8.0mm | In distribution |
| 5484865 | D=6.5mm | In distribution |
| 7756384 | 5.0mm | In distribution |
| EX1214001 | 3.5mm | In distribution |
| 873-008 | 4.0mm | In distribution |
| X0615097 | 5.0mm | In distribution |
| 8686509 | DIA=6.5mm | In distribution |
| 8350424 | 5.5mm | In distribution |
| 8350300 | In distribution | |
| 2030016 | 4mm | In distribution |
| X0615099 | 6.0mm | In distribution |
| EX0516081 | 9.5mm | In distribution |
| X0810716 | 8.0mm | In distribution |
| EX0211168 | 5.5mm | In distribution |
| 876-472 | 4.0mm x 13mm | In distribution |
| EX0114040 | 8.0mm | In distribution |
| EX0211176 | 9.5mm | In distribution |
| EX0516078 | 8.0mm | In distribution |
| EX0516070 | 4.0mm | In distribution |
| 8350380 | 4.5mm | In distribution |
| X0810718 | 9.0mm | In distribution |
| 7080920 | 4.0X13mm | In distribution |
| 8685000 | DIA=5.0mm | In distribution |
| EX0211164 | 3.75mm | In distribution |
| EX0217072 | 4.5mm | In distribution |
| EX0117068 | 3.0mm | In distribution |
| 900-642 | 16mm | In distribution |
| EX0817010 | In distribution | |
| 8350299 | In distribution | |
| EX1115034 | 4.0mm | In distribution |
| 3606055 | In distribution | |
| EX1115033 | 3.5mm | In distribution |
| EX0211171 | 7.0mm | In distribution |
| 8231331 | 6.5mm | In distribution |
| EX0516071 | 4.5mm | In distribution |
| EX1016096 | 3.75mm | In distribution |
| 8670045 | 4.5mm | In distribution |
| X0810710 | 5.0mm | In distribution |
| EX0914105 | In distribution | |
| EX0116029 | 4.5mm | In distribution |
| X0315089 | 5.0mm | In distribution |
| 7756337 | 5.0mm | In distribution |
| EX1014044 | 6.0mm | In distribution |
| 9870065 | In distribution | |
| EX0115075 | 5.5mm | In distribution |
| 3606045 | 4.5mm | In distribution |
| EX0117069 | 3.5mm | In distribution |
| X0810712 | 6.0mm | In distribution |
| EX0215118 | 6.5mm | In distribution |
| EX0217054 | 3.5mm | In distribution |
| EX0213060 | 8.5mm | In distribution |
| 8350383 | 7.5mm | In distribution |
| X0615100 | 6.5mm | In distribution |
| 8674000 | In distribution | |
| EX0811517 | 6.5mm | In distribution |
| 7756040 | 4.0mm | In distribution |
| 3600451 | 4.5mm | In distribution |
| EX0211165 | 4.0mm | In distribution |
| 3606035 | 3.5mm | In distribution |
| 8350381 | 5.5mm | In distribution |
| 3600450 | 4.5mm | In distribution |
| EX0811518 | 5.5mm | In distribution |
| 8230928 | In distribution | |
| 8350430 | 8.5mm | In distribution |
| 8616155 | In distribution | |
| 8670075 | In distribution | |
| 6860472 | 4.0 x 13mm | In distribution |
| 5484887 | D=5.5mm-6.5mm | In distribution |
| X1212045 | 3.0mm | In distribution |
| 836-016 | DIA=6.5mm | In distribution |
| X0810709 | 4.5mm | In distribution |
| EX1016102 | 6.5mm | In distribution |
| EX0116032 | 7.5mm | In distribution |
| EX0516079 | 8.5mm | In distribution |
| 8350380 | In distribution | |
| 8231330 | 5.5mm | In distribution |
| X0315090 | 5.5mm | In distribution |
| 876-478 | 4.5mm x 13mm | In distribution |
| 5484875 | D=7.5mm | In distribution |
| X09103875 | 7.5mm | Withdrawn |
| 8920812 | 12mm | Withdrawn |
| 9030244 | 14mm | Withdrawn |
| 9030441 | 18mm | Withdrawn |
| 8920814 | 14mm | Withdrawn |
| X0315016 | 4.5mm | Withdrawn |
| X1009012 | 4.0mm | Withdrawn |
| X1214005 | 4.5mm | Withdrawn |
| X09103869 | 4.5mm | Withdrawn |
| X0315018 | 5.5mm | Withdrawn |
| X09103877 | 8.5mm | Withdrawn |
| X0315020 | 6.5mm | Withdrawn |
| X1214006 | 5.5mm | Withdrawn |
| X0315021 | 7.5mm | Withdrawn |
| X0108004 | Withdrawn | |
| X1009013 | 4.5mm | Withdrawn |
| X1010022 | 8.5mm | Withdrawn |
| X0705035 | Withdrawn | |
| X0108003 | Withdrawn | |
| X0109636 | Withdrawn | |
| X1009014 | 5.0mm | Withdrawn |
| X09103878 | 9.0mm | Withdrawn |
| 9030341 | 16mm | Withdrawn |
| X0315017 | 5.0mm | Withdrawn |
| X09103874 | 7.0mm | Withdrawn |
| X09103876 | 8.0mm | Withdrawn |
| 8231926 | Withdrawn | |
| X0315015 | 4.0mm | Withdrawn |
| EX0411312 | Withdrawn | |
| X0315019 | 6.0mm | Withdrawn |
| X09103870 | 5.0mm | Withdrawn |
| X1014004 | Withdrawn | |
| 8786500 | D=6.5mm | Withdrawn |
| X1010056 | 9.5mm | Withdrawn |
| X09103872 | 6.0mm | Withdrawn |
| X1214007 | 6.5mm | Withdrawn |
| X0108066 | Withdrawn | |
| 9030541 | 20mm | Withdrawn |
| X8683509 | 3.5mm | Withdrawn |
| X09103879 | 9.5mm | Withdrawn |
| EX0211175 | 9.0mm | Withdrawn |
| X09103871 | 5.5mm | Withdrawn |
| X0109635 | Withdrawn | |
| X0108002 | Withdrawn | |
| X1214008 | 7.5mm | Withdrawn |
| X09103873 | 6.5mm | 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 | 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 |
| Anax 5.5™ Spinal System | CG MedTech Co., Ltd. | 65 |
Showing 12 of 545. All products under Tap, Bone
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | UDI-DI | 2021-03-23 | Class III | Device Design | Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter. | 154,152 units | 2026-08-04 |
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.