The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biolok Micro-lok Implant System.
| Device ID | K081818 |
| 510k Number | K081818 |
| Device Name: | BIOLOK MICRO-LOK IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Contact | Michael Davis |
| Correspondent | Michael Davis BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-27 |
| Decision Date | 2008-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236003173 | K081818 | 000 |
| 00847236000219 | K081818 | 000 |
| 00847236002947 | K081818 | 000 |
| 00847236002954 | K081818 | 000 |
| 00847236002961 | K081818 | 000 |
| 00847236002978 | K081818 | 000 |
| 00847236002985 | K081818 | 000 |
| 00847236003012 | K081818 | 000 |
| 00847236003029 | K081818 | 000 |
| 00847236003036 | K081818 | 000 |
| 00847236003043 | K081818 | 000 |
| 00847236003050 | K081818 | 000 |
| 00847236003067 | K081818 | 000 |
| 00847236003128 | K081818 | 000 |
| 00847236003135 | K081818 | 000 |
| 00847236003142 | K081818 | 000 |
| 00847236003159 | K081818 | 000 |
| 00847236003166 | K081818 | 000 |
| 00847236000202 | K081818 | 000 |