The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Self Tapping Cancellous Bone Screws.
| Device ID | K894124 |
| 510k Number | K894124 |
| Device Name: | OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Pat Kramer |
| Correspondent | Pat Kramer OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-09-11 |