The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Total Elbow System.
| Device ID | K980502 |
| 510k Number | K980502 |
| Device Name: | OSTEONICS TOTAL ELBOW SYSTEM |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Kate Sutton |
| Correspondent | Kate Sutton OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327138306 | K980502 | 000 |
| 07613327137507 | K980502 | 000 |
| 07613327014105 | K980502 | 000 |
| 07613327014013 | K980502 | 000 |
| 07613327014006 | K980502 | 000 |
| 07613327013993 | K980502 | 000 |
| 37613327590075 | K980502 | 000 |
| 37613327590051 | K980502 | 000 |
| 07613327627251 | K980502 | 000 |
| 07613327627244 | K980502 | 000 |
| 07613327627435 | K980502 | 000 |
| 07613327627428 | K980502 | 000 |
| 07613327627411 | K980502 | 000 |
| 07613327137514 | K980502 | 000 |
| 07613327137538 | K980502 | 000 |
| 07613327137552 | K980502 | 000 |
| 07613327137835 | K980502 | 000 |
| 07613327137705 | K980502 | 000 |
| 07613327137651 | K980502 | 000 |
| 07613327137644 | K980502 | 000 |
| 07613327137637 | K980502 | 000 |
| 07613327137620 | K980502 | 000 |
| 07613327137613 | K980502 | 000 |
| 07613327137606 | K980502 | 000 |
| 07613327137590 | K980502 | 000 |
| 07613327137583 | K980502 | 000 |
| 07613327137576 | K980502 | 000 |
| 07613327137569 | K980502 | 000 |
| 07613327627404 | K980502 | 000 |