Aequalis Reversed II
Tap Stopper
12manufacturers in China registered for this device type
2catalogue numbers in this listing
3recalls on this code
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 | Tornier Inc., United States |
|---|---|
| FDA product code | HWX |
| Device type | Tap, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-08-08 |
| Record revised | 2024-03-14 (version 4) |
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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MWF714 | In distribution | |
| MWF716 | In distribution |
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 |
|---|---|---|---|---|---|
| 2010-10-15 | Not classified | Device Design | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length | 2012-09-06 | |
| 2010-10-15 | Not classified | Device Design | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length | 2 | 2012-09-06 |
| 2010-10-15 | Not classified | Device Design | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length | 2012-09-06 |
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.