The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Ceramic Morse Taper Head (1002 Series).
| Device ID | K885102 |
| 510k Number | K885102 |
| Device Name: | OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540169457 | K885102 | 000 |