The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Frs Screw.
| Device ID | K062352 |
| 510k Number | K062352 |
| Device Name: | FRS SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Contact | Rebecca Lennard |
| Correspondent | Rebecca Lennard DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-11 |
| Decision Date | 2006-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868116230 | K062352 | 000 |
| 00887868057670 | K062352 | 000 |
| 00887868057663 | K062352 | 000 |
| 00887868057656 | K062352 | 000 |
| 00887868057649 | K062352 | 000 |
| 00887868057632 | K062352 | 000 |
| 00887868057625 | K062352 | 000 |
| 00887868057618 | K062352 | 000 |
| 00887868057601 | K062352 | 000 |
| 00887868057595 | K062352 | 000 |
| 00887868057588 | K062352 | 000 |
| 00887868057571 | K062352 | 000 |
| 00887868057564 | K062352 | 000 |
| 00887868057557 | K062352 | 000 |
| 00887868057540 | K062352 | 000 |
| 00887868057687 | K062352 | 000 |
| 00887868057694 | K062352 | 000 |
| 00887868057700 | K062352 | 000 |
| 00887868116223 | K062352 | 000 |
| 00887868116216 | K062352 | 000 |
| 00887868116209 | K062352 | 000 |
| 00887868116193 | K062352 | 000 |
| 00887868115738 | K062352 | 000 |
| 00887868115721 | K062352 | 000 |
| 00887868115677 | K062352 | 000 |
| 00887868115660 | K062352 | 000 |
| 00887868115653 | K062352 | 000 |
| 00887868115646 | K062352 | 000 |
| 00887868115639 | K062352 | 000 |
| 00887868115622 | K062352 | 000 |
| 00887868057724 | K062352 | 000 |
| 00887868057717 | K062352 | 000 |
| 00887868057533 | K062352 | 000 |