The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Ii Epf Hip Stem Series.
| Device ID | K911585 |
| 510k Number | K911585 |
| Device Name: | OMNIFIT II EPF HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| 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 | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153324423 | K911585 | 000 |
| 07613153324348 | K911585 | 000 |
| 07613153324355 | K911585 | 000 |
| 07613153324362 | K911585 | 000 |
| 07613153324379 | K911585 | 000 |
| 07613153324386 | K911585 | 000 |
| 07613153324393 | K911585 | 000 |
| 07613153324409 | K911585 | 000 |
| 07613153324416 | K911585 | 000 |
| 07613153324331 | K911585 | 000 |