The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Rockwood Clavicle Pin.
| Device ID | K991649 |
| 510k Number | K991649 |
| Device Name: | DEPUY ROCKWOOD CLAVICLE PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Sally Foust |
| Correspondent | Sally Foust DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-13 |
| Decision Date | 1999-07-14 |
| Summary: | summary |