The following data is part of a premarket notification filed by Curvafix, Inc. with the FDA for Curvafix Intramedullary Rodscrew System.
| Device ID | K180050 |
| 510k Number | K180050 |
| Device Name: | CurvaFix Intramedullary Rodscrew System |
| Classification | Screw, Fixation, Bone |
| Applicant | CurvaFix, Inc. 1000 124th Ave NE Suite100 Bellevue, WA 98005 |
| Contact | Steve Dimmer |
| Correspondent | Karen E. Warden BackRoads Consulting PO BOX 566 Chesterland, OH 44026 -0566 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-08 |
| Decision Date | 2019-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855068008409 | K180050 | 000 |
| 10855068008553 | K180050 | 000 |
| 10855068008423 | K180050 | 000 |
| 10855068008492 | K180050 | 000 |
| 10855068008539 | K180050 | 000 |
| 10855068008003 | K180050 | 000 |
| 10855068008010 | K180050 | 000 |
| 10855068008027 | K180050 | 000 |
| 10855068008034 | K180050 | 000 |
| 10855068008041 | K180050 | 000 |
| 10855068008058 | K180050 | 000 |
| 10855068008065 | K180050 | 000 |
| 10855068008072 | K180050 | 000 |
| 10855068008089 | K180050 | 000 |
| 10855068008096 | K180050 | 000 |
| 10855068008102 | K180050 | 000 |
| 10855068008348 | K180050 | 000 |
| 10855068008393 | K180050 | 000 |
| 10855068008546 | K180050 | 000 |