The following data is part of a premarket notification filed by The Stern Metals Co., Inc. with the FDA for Impla-med Hex Screw Implants: 4,5 & 6mm Diameter.
| Device ID | K926305 |
| 510k Number | K926305 |
| Device Name: | IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER |
| Classification | Implant, Endosseous, Root-form |
| Applicant | THE STERN METALS CO., INC. 23 FRANK MOSSBERG DR. Attleboro, MA 02703 |
| Contact | Walton Jr |
| Correspondent | Walton Jr THE STERN METALS CO., INC. 23 FRANK MOSSBERG DR. Attleboro, MA 02703 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-15 |
| Decision Date | 1994-03-01 |