The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Bone Screw.
| Device ID | K873251 |
| 510k Number | K873251 |
| Device Name: | OMNIFIT BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane 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 | 1987-08-17 |
| Decision Date | 1987-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327037074 | K873251 | 000 |
| 07613327036862 | K873251 | 000 |
| 07613327036855 | K873251 | 000 |
| 07613327036848 | K873251 | 000 |
| 07613327036831 | K873251 | 000 |
| 07613327036824 | K873251 | 000 |
| 07613327036817 | K873251 | 000 |
| 07613327036800 | K873251 | 000 |
| 07613327036794 | K873251 | 000 |
| 07613327036787 | K873251 | 000 |
| 07613327036770 | K873251 | 000 |
| 07613327036763 | K873251 | 000 |
| 07613327036756 | K873251 | 000 |
| 07613327036749 | K873251 | 000 |
| 07613327036732 | K873251 | 000 |
| 07613327036725 | K873251 | 000 |
| 07613327036718 | K873251 | 000 |
| 07613327036701 | K873251 | 000 |
| 07613327036879 | K873251 | 000 |
| 07613327036886 | K873251 | 000 |
| 07613327037050 | K873251 | 000 |
| 07613327037043 | K873251 | 000 |
| 07613327037036 | K873251 | 000 |
| 07613327037029 | K873251 | 000 |
| 07613327037012 | K873251 | 000 |
| 07613327037005 | K873251 | 000 |
| 07613327036992 | K873251 | 000 |
| 07613327036985 | K873251 | 000 |
| 07613327036978 | K873251 | 000 |
| 07613327036961 | K873251 | 000 |
| 07613327036954 | K873251 | 000 |
| 07613327036947 | K873251 | 000 |
| 07613327036930 | K873251 | 000 |
| 07613327036923 | K873251 | 000 |
| 07613327036916 | K873251 | 000 |
| 07613327036909 | K873251 | 000 |
| 07613327036893 | K873251 | 000 |
| 07613327036688 | K873251 | 000 |