The following data is part of a premarket notification filed by Extremity Medical, Llc. with the FDA for Axis Charcot Fixation System.
| Device ID | K211261 |
| 510k Number | K211261 |
| Device Name: | Axis Charcot Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Contact | Mary Hoffman |
| Correspondent | Mary Hoffman Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-05-28 |