The following data is part of a premarket notification filed by Extremity Medical, Llc with the FDA for Align Anterior Ankle Fusion Plate.
| Device ID | K160191 |
| 510k Number | K160191 |
| Device Name: | Align Anterior Ankle Fusion Plate |
| Classification | Plate, Fixation, Bone |
| Applicant | Extremity Medical, LLC 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Contact | Brian Smekal |
| Correspondent | Brian Smekal Extremity Medical, LLC 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-03-25 |
| Summary: | summary |