The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteo Kirschner Wires.
| Device ID | K971962 |
| 510k Number | K971962 |
| Device Name: | OSTEO KIRSCHNER WIRES |
| Classification | Pin, Fixation, Smooth |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Terry Sheridan |
| Correspondent | Terry Sheridan OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-28 |
| Decision Date | 1997-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540066794 | K971962 | 000 |
| 37613327072441 | K971962 | 000 |
| 37613327072465 | K971962 | 000 |
| 37613327072489 | K971962 | 000 |
| 37613327072496 | K971962 | 000 |
| 37613327072526 | K971962 | 000 |
| 37613327072540 | K971962 | 000 |
| 37613327072625 | K971962 | 000 |
| 37613327072649 | K971962 | 000 |
| 37613327072656 | K971962 | 000 |
| 37613327072663 | K971962 | 000 |
| 04546540066770 | K971962 | 000 |
| 04546540066787 | K971962 | 000 |
| 07613327072631 | K971962 | 000 |