The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics X Cemented Hip Stem Series.
| Device ID | K983226 |
| 510k Number | K983226 |
| Device Name: | OSTEONICS X CEMENTED HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton 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 | 1998-09-15 |
| Decision Date | 1998-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327022575 | K983226 | 000 |
| 07613327022384 | K983226 | 000 |
| 07613327022391 | K983226 | 000 |
| 07613327022407 | K983226 | 000 |
| 07613327022421 | K983226 | 000 |
| 07613327022438 | K983226 | 000 |
| 07613327022445 | K983226 | 000 |
| 07613327022452 | K983226 | 000 |
| 07613327022469 | K983226 | 000 |
| 07613327022476 | K983226 | 000 |
| 07613327022483 | K983226 | 000 |
| 07613327022490 | K983226 | 000 |
| 07613327022513 | K983226 | 000 |
| 07613327022544 | K983226 | 000 |
| 07613327022568 | K983226 | 000 |
| 07613327022360 | K983226 | 000 |