The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Shoulder Humeral Components.
| Device ID | K955731 |
| 510k Number | K955731 |
| Device Name: | OSTEONICS SHOULDER HUMERAL COMPONENTS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Tery Jarosz |
| Correspondent | Tery Jarosz OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327139594 | K955731 | 000 |
| 07613327139402 | K955731 | 000 |
| 07613327139426 | K955731 | 000 |
| 07613327139433 | K955731 | 000 |
| 07613327139457 | K955731 | 000 |
| 07613327139464 | K955731 | 000 |
| 07613327139471 | K955731 | 000 |
| 07613327139488 | K955731 | 000 |
| 07613327139495 | K955731 | 000 |
| 07613327139501 | K955731 | 000 |
| 07613327139518 | K955731 | 000 |
| 07613327139525 | K955731 | 000 |
| 07613327139532 | K955731 | 000 |
| 07613327139549 | K955731 | 000 |
| 07613327139556 | K955731 | 000 |
| 07613327139563 | K955731 | 000 |
| 07613327139570 | K955731 | 000 |
| 07613327139587 | K955731 | 000 |
| 07613327139372 | K955731 | 000 |