The following data is part of a premarket notification filed by Impla-med with the FDA for Impla-med Hex Screw Implants, 18 And 20 Mm.
| Device ID | K921854 |
| 510k Number | K921854 |
| Device Name: | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325 |
| Contact | Walton, Jr |
| Correspondent | Walton, Jr IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1992-10-27 |