The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Orthosorb Resorbable Pins.
| Device ID | K111077 |
| 510k Number | K111077 |
| Device Name: | ORTHOSORB RESORBABLE PINS |
| Classification | Pin, Fixation, Resorbable, Hard Tissue |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 |
| Product Code | OVZ |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-07-12 |
| Summary: | summary |