DIRECTguide™ Guided Step Drill
30 catalogue numbers from GSD2.8-13, listed by Implant Direct Sybron Manufacturing LLC, United States, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
30catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Implant Direct Sybron Manufacturing LLC, United States |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K231087 |
| Record published | 2024-05-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GSD2.8-13 | 2.8 X 13 | In distribution |
| GSD2.3-10 | 2.3 X 10 | In distribution |
| GSD2.8-10 | 2.8 X 10 | In distribution |
| GSD2.8-16 | 2.8 X 16 | In distribution |
| GSD2.3-11 | 2.3 X 11.5 | In distribution |
| GSD3.4-13 | 3.4 X 13 | In distribution |
| GSD3.8-8 | 3.8 X 8 | In distribution |
| GSD3.4-8 | 3.4 X 8 | In distribution |
| GSD3.4-11 | 3.4 X 11.5 | In distribution |
| GSD4.8-8 | 4.8 X 8 | In distribution |
| GSD4.4-16 | 4.4 X 16 | In distribution |
| GSD4.8-13 | 4.8 X 13 | In distribution |
| GSD4.8-11 | 4.8 X 11.5 | In distribution |
| GSD3.8-11 | 3.8 X 11.5 | In distribution |
| GSD4.4-11 | 4.4 X 11.5 | In distribution |
| GSD2.8-8 | 2.8 X 8 | In distribution |
| GSD4.8-16 | 4.8 X 16 | In distribution |
| GSD3.4-16 | 3.4 X 16 | In distribution |
| GSD3.4-10 | 3.4 X 10 | In distribution |
| GSD2.3-8 | 2.3 X 8 | In distribution |
| GSD3.8-16 | 3.8 X 16 | In distribution |
| GSD4.8-10 | 4.8 X 10 | In distribution |
| GSD3.8-10 | 3.8 X 10 | In distribution |
| GSD4.4-10 | 4.4 X 10 | In distribution |
| GSD4.4-13 | 4.4 X 13 | In distribution |
| GSD2.3-13 | 2.3 X 13 | In distribution |
| GSD2.3-16 | 2.3 X 16 | In distribution |
| GSD3.8-13 | 3.8 X 13 | In distribution |
| GSD2.8-11 | 2.8 X 11.5 | In distribution |
| GSD4.4-8 | 4.4 X 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231087 | 2023-08-16 |
| K200265 | 2020-06-30 |
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.