Drill, Bone, Powered
Screwholder Insert FOR Screws 1.5 & 2.0MM DIA F/90° Scrwdrvr
2manufacturers in China registered for this device type
150catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K043310 |
| Record published | 2018-09-21 |
| Record revised | 2022-07-14 (version 8) |
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, serial number |
| Distribution end date | 2026-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310.510 | In distribution | |
| SD316.447 | In distribution | |
| SD03.503.414 | In distribution | |
| 310.523 | In distribution | |
| 05.001.032 | In distribution | |
| 03.000.072S | In distribution | |
| 317.852 | In distribution | |
| 03.000.141S | In distribution | |
| 03.000.308S | In distribution | |
| 05.001.111 | In distribution | |
| 03.505.006 | In distribution | |
| 03.505.065 | In distribution | |
| 310.542 | In distribution | |
| 316.235 | In distribution | |
| SD316.440 | In distribution | |
| SD310.050 | In distribution | |
| 317.72 | In distribution | |
| 310.522 | In distribution | |
| 03.000.001S | In distribution | |
| SD03.503.720 | In distribution | |
| 03.000.036S | In distribution | |
| 03.000.304S | In distribution | |
| 316.15 | In distribution | |
| 317.12 | In distribution | |
| 03.505.087 | In distribution | |
| SD03.503.510 | In distribution | |
| SD03.503.506 | In distribution | |
| 03.000.181S | In distribution | |
| 03.505.011 | In distribution | |
| 317.875 | In distribution | |
| 05.001.120 | In distribution | |
| SD03.503.512 | In distribution | |
| 03.000.234S | In distribution | |
| 03.500.000 | In distribution | |
| 316.440 | In distribution | |
| 316.25 | In distribution | |
| 317.878 | In distribution | |
| SD03.503.708 | In distribution | |
| 03.000.321S | In distribution | |
| 05.505.002 | In distribution | |
| 05.001.045 | In distribution | |
| SD03.503.508 | In distribution | |
| SD03.503.416 | In distribution | |
| SD03.503.714 | In distribution | |
| 387.641 | In distribution | |
| SD03.503.476 | In distribution | |
| 05.001.047 | In distribution | |
| 03.000.332S | In distribution | |
| 03.000.184S | In distribution | |
| SD310.040 | In distribution | |
| 310.173 | In distribution | |
| 316.13 | In distribution | |
| 03.000.088S | In distribution | |
| 03.000.182S | In distribution | |
| 317.855 | In distribution | |
| 03.000.018S | In distribution | |
| 310.21.98 | In distribution | |
| 03.000.030S | In distribution | |
| 03.505.047 | In distribution | |
| 310.172 | In distribution | |
| SD03.503.718 | In distribution | |
| 03.000.188S | In distribution | |
| 387.631 | In distribution | |
| 03.000.105S | In distribution | |
| 03.000.305S | In distribution | |
| 03.000.083S | In distribution | |
| SD03.503.410 | In distribution | |
| SD03.503.710 | In distribution | |
| 03.000.151S | In distribution | |
| 05.001.021 | In distribution | |
| 05.001.099 | In distribution | |
| 05.001.027 | In distribution | |
| 03.305.004 | In distribution | |
| SD03.503.418 | In distribution | |
| 03.505.004 | In distribution | |
| 397.284 | In distribution | |
| 03.000.080S | In distribution | |
| 03.000.191S | In distribution | |
| 317.82 | In distribution | |
| 310.513 | In distribution | |
| SD310.173 | In distribution | |
| 03.505.030 | In distribution | |
| 310.512 | In distribution | |
| 310.15.98 | In distribution | |
| SD03.503.518 | In distribution | |
| 317.62 | In distribution | |
| 317.835 | In distribution | |
| 03.000.152S | In distribution | |
| 03.000.174S | In distribution | |
| 310.16.98 | In distribution | |
| 317.876 | In distribution | |
| 310.543 | In distribution | |
| 317.858 | In distribution | |
| 05.001.029 | In distribution | |
| 03.000.362S | In distribution | |
| 03.000.060S | In distribution | |
| 03.000.363S | In distribution | |
| 05.001.012 | In distribution | |
| 310.540 | In distribution | |
| 05.001.048 | In distribution | |
| 317.14 | In distribution | |
| 03.000.052S | In distribution | |
| 03.000.311S | In distribution | |
| 03.000.134S | In distribution | |
| SD03.503.716 | In distribution | |
| 03.000.042S | In distribution | |
| 03.000.310S | In distribution | |
| 316.614 | In distribution | |
| SD03.503.722 | In distribution | |
| 03.000.039S | In distribution | |
| 03.315.011 | In distribution | |
| SD03.503.712 | In distribution | |
| SD03.503.422 | In distribution | |
| 03.000.364S | In distribution | |
| SD03.503.706 | In distribution | |
| 05.001.050 | In distribution | |
| 317.335 | In distribution | |
| 310.520 | In distribution | |
| 310.532 | In distribution | |
| SD03.503.516 | In distribution | |
| 310.530 | In distribution | |
| SD03.503.520 | In distribution | |
| 03.000.238S | In distribution | |
| 317.836 | In distribution | |
| SD03.503.420 | In distribution | |
| 310.170 | In distribution | |
| 03.315.010 | In distribution | |
| 03.505.085 | In distribution | |
| SD03.511.010 | In distribution | |
| SD03.503.704 | In distribution | |
| 05.001.067 | In distribution | |
| 397.283 | In distribution | |
| 317.877 | In distribution | |
| 03.505.044 | In distribution | |
| 03.000.145S | In distribution | |
| SD03.503.514 | In distribution | |
| 03.505.010 | In distribution | |
| SD310.019 | In distribution | |
| 312.157 | In distribution | |
| 03.000.061S | In distribution | |
| 03.000.196S | In distribution | |
| 05.001.094 | In distribution | |
| 03.000.328S | In distribution | |
| 03.000.161S | Withdrawn | |
| 03.000.063S | Withdrawn | |
| 03.000.221S | Withdrawn | |
| 05.001.043 | Withdrawn | |
| 03.000.136S | Withdrawn | |
| 03.000.099S | Withdrawn | |
| 05.001.017 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Satelec | 87 |
| Neoss Implant System | Neoss AB | 74 |
| Mectron | Mectron SPA | 48 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
| Drill, Bone, Powered | Synthes (U.S.A.) LP | 19 |
Showing 12 of 265. All products under Drill, Bone, Powered
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2016-11-01 | Class II | Under Investigation by firm | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. | 84 units | 2017-06-01 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-06-24 | Class I | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. | 1,833 devices (05.001.024 and 05.001.108) | 2018-06-09 |
| THE Anspach Effort, Inc. | 510(k) number | 2016-06-24 | Class I | Device Design | There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. | 1,833 devices (05.001.024 and 05.001.108) | 2018-06-09 |
| Synthes (USA) Products LLC | 510(k) number | 2016-05-31 | Class II | Labeling False and Misleading | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard. | 19 units | 2017-02-02 |
| Synthes Gmbh | 510(k) number | 2014-12-19 | Class II | Process design | In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged. | 249 | 2016-05-19 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-04-15 | Class II | Process design | Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The “on” and “lock” labels were interchanged. | 290 | 2016-09-14 |
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.