The following data is part of a premarket notification filed by Curvafix, Inc. with the FDA for Curvafix Im System.
| Device ID | K222505 |
| 510k Number | K222505 |
| Device Name: | CurvaFix IM System |
| Classification | Screw, Fixation, Bone |
| Applicant | CurvaFix, Inc. 1406 Place NE Suite 107 Bellevue, WA 98007 |
| Contact | Steve Dimmer |
| Correspondent | Lisa Pritchard Duval & Associates, P.A. 825 Nicollet Mall Medical Arts Building Suite 1820 Minneapolis, MN 55402 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855068008720 | K222505 | 000 |
| 10855068008638 | K222505 | 000 |
| 10855068008645 | K222505 | 000 |
| 10855068008652 | K222505 | 000 |
| 10855068008669 | K222505 | 000 |
| 10855068008676 | K222505 | 000 |
| 10855068008683 | K222505 | 000 |
| 10855068008690 | K222505 | 000 |
| 10855068008706 | K222505 | 000 |
| 10855068008713 | K222505 | 000 |
| 10855068008737 | K222505 | 000 |