The following data is part of a premarket notification filed by Osteomed with the FDA for Extremilock Lateral Ankle Fusion Plates.
| Device ID | K203479 |
| 510k Number | K203479 |
| Device Name: | ExtremiLOCK Lateral Ankle Fusion Plates |
| Classification | Plate, Fixation, Bone |
| Applicant | OsteoMed 3885 Arapaho Road Addison, TX 75001 |
| Contact | Andrew Johnson |
| Correspondent | Andrew Johnson OsteoMed 3885 Arapaho Road Addison, TX 75001 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842528128985 | K203479 | 000 |
| 00842528128978 | K203479 | 000 |
| 00842528128961 | K203479 | 000 |
| 00842528128954 | K203479 | 000 |
| 00842528128947 | K203479 | 000 |