The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Rockwood Clavicle Pins.
| Device ID | K103001 |
| 510k Number | K103001 |
| Device Name: | ROCKWOOD CLAVICLE PINS |
| Classification | Pin, Fixation, Threaded |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Suzanna Otano |
| Correspondent | Suzanna Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE 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 | 2010-10-06 |
| Decision Date | 2011-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868010842 | K103001 | 000 |
| 00887868449208 | K103001 | 000 |
| 00887868449215 | K103001 | 000 |
| 00887868449222 | K103001 | 000 |
| 00887868449239 | K103001 | 000 |
| 00887868010804 | K103001 | 000 |
| 00887868010811 | K103001 | 000 |
| 00887868010828 | K103001 | 000 |
| 00887868010835 | K103001 | 000 |
| 00887868449192 | K103001 | 000 |