The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Micro-structured Hs3p Proportional Series Hip Stem.
| Device ID | K844817 |
| 510k Number | K844817 |
| Device Name: | MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert G Averill |
| Correspondent | Robert G Averill OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-11 |
| Decision Date | 1985-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327016451 | K844817 | 000 |
| 07613327016352 | K844817 | 000 |
| 07613327016369 | K844817 | 000 |
| 07613327016376 | K844817 | 000 |
| 07613327016383 | K844817 | 000 |
| 07613327016390 | K844817 | 000 |
| 07613327016406 | K844817 | 000 |
| 07613327016413 | K844817 | 000 |
| 07613327016420 | K844817 | 000 |
| 07613327016437 | K844817 | 000 |
| 07613327016444 | K844817 | 000 |
| 07613327016345 | K844817 | 000 |