The following data is part of a premarket notification filed by Intra-lock International with the FDA for Intra-lock Hydroxyapatite Coated Implants.
| Device ID | K031322 |
| 510k Number | K031322 |
| Device Name: | INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTRA-LOCK INTERNATIONAL 1200 N. FEDERAL HWY SUITE#200 Boca Raton, FL 33432 |
| Contact | Jeffery Sakoff |
| Correspondent | Jeffery Sakoff INTRA-LOCK INTERNATIONAL 1200 N. FEDERAL HWY SUITE#200 Boca Raton, FL 33432 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-25 |
| Decision Date | 2003-12-23 |
| Summary: | summary |