The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics(r) Ccr Hip Stem Series.
| Device ID | K945574 |
| 510k Number | K945574 |
| Device Name: | OSTEONICS(R) CCR HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch |
| Correspondent | Robert A Koch OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327021967 | K945574 | 000 |
| 07613327021943 | K945574 | 000 |
| 07613327021936 | K945574 | 000 |
| 07613327021929 | K945574 | 000 |
| 07613327021912 | K945574 | 000 |
| 07613327021905 | K945574 | 000 |
| 07613327021875 | K945574 | 000 |