The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for 1.5mm Small Locking Plate, 1.5mm Non-locking And Locking Screws.
| Device ID | K090492 |
| 510k Number | K090492 |
| Device Name: | 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-03-31 |
| Summary: | summary |