The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Argulated Locking Plates.
| Device ID | K143338 |
| 510k Number | K143338 |
| Device Name: | Argulated Locking Plates |
| Classification | Plate, Bone |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Anita Zacherl |
| Correspondent | Anita Zacherl OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-20 |
| Decision Date | 2015-04-01 |
| Summary: | summary |