ALPHA BIO BONE FIXATION SCREW SYSTEM
FDA 510(k) clearance K063769 · decided 2007-03-30
Clearance details
- K-number
- K063769
- Device name
- ALPHA BIO BONE FIXATION SCREW SYSTEM
- Applicant
- Alpha-Bio Tec , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-20
- Decision date
- 2007-03-30
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- DZL
- Device class
- 2
- Regulation number
- 872.4880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| KLS Martin Drill-Free MMF Screw (K233721) | KLS-Martin L.P. | 2024-09-17 |
| Stryker MP, Mandible, HMMF and MMF AXS Screws (K231599) | Stryker Leibinger GmbH & Co KG | 2023-08-24 |
| SAVE GBR (K222367) | Dentis Co., Ltd. | 2023-03-23 |
| The Micro Screw System, Micro Screw System Basic (K201210) | Hager& Meisinger GmbH | 2021-10-08 |
| Membrane Screws and Membrane Tacks (K201561) | Neoss Limited | 2020-10-05 |
| Bone Screw, Bone Tack (K182881) | Osstem Implant Co., Ltd. | 2019-08-09 |
| OssBuilder System (K181854) | Osstem Implant Co., Ltd. | 2019-05-07 |
Recalls involving this device
No recalls on record reference this clearance.