The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for 2.5 Mm Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 Mm Locking Screws, Models 131220408-131220424.
| Device ID | K083364 |
| 510k Number | K083364 |
| Device Name: | 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-13 |
| Decision Date | 2008-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868011337 | K083364 | 000 |
| 00887868449840 | K083364 | 000 |
| 00887868449833 | K083364 | 000 |
| 00887868449826 | K083364 | 000 |
| 00887868449819 | K083364 | 000 |
| 00887868449802 | K083364 | 000 |
| 00887868449796 | K083364 | 000 |
| 00887868546594 | K083364 | 000 |
| 00887868546570 | K083364 | 000 |
| 00887868449857 | K083364 | 000 |
| 00887868449864 | K083364 | 000 |
| 00887868011313 | K083364 | 000 |
| 00887868011290 | K083364 | 000 |
| 00887868452598 | K083364 | 000 |
| 00887868452581 | K083364 | 000 |
| 00887868452574 | K083364 | 000 |
| 00887868452567 | K083364 | 000 |
| 00887868452550 | K083364 | 000 |
| 00887868452543 | K083364 | 000 |
| 00887868546556 | K083364 | 000 |