The following data is part of a premarket notification filed by Mathys Corp. Of North America with the FDA for Ha-ti (hand-titanium Screw) Implant.
| Device ID | K901927 |
| 510k Number | K901927 |
| Device Name: | HA-TI (HAND-TITANIUM SCREW) IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MATHYS CORP. OF NORTH AMERICA 7 GREAT VALLEY PKWY. SUITE 223 Malvern, PA 19355 |
| Contact | Heinz E Wick |
| Correspondent | Heinz E Wick MATHYS CORP. OF NORTH AMERICA 7 GREAT VALLEY PKWY. SUITE 223 Malvern, PA 19355 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1991-01-04 |