Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K252019
CurvaFix Low Profile System · Curvafix, Inc. · decided 2025-08-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CurvaFix® Low Profile Implant | 9.5 mm x 100 mm | CURVAFIX, INC. | HWC | 10850070500132 |
| Sterilization Tray, Lid | CTL-001-LP | CURVAFIX, INC. | HWC | 10850070500675 |
| CurvaFix® Low Profile Implant | 7.5 mm x 120 mm | CURVAFIX, INC. | HWC | 10850070500286 |
| CurvaFix® Low Profile Implant | 7.5 mm x 90 mm | CURVAFIX, INC. | HWC | 10850070500255 |
| CurvaFix® Low Profile Implant | 7.5 mm x 150 mm | CURVAFIX, INC. | HWC | 10850070500316 |
| Cannulated Connecting Bolt | CCB-001-LP | CURVAFIX, INC. | HWC | 10850070500521 |
| CurvaFix® Low Profile Implant | 9.5 mm x 190 mm | CURVAFIX, INC. | HWC | 10850070500224 |
| CurvaFix Low Profile Instrument Set | CIS-004-LP | CURVAFIX, INC. | HWC | 10850070500637 |
| CurvaFix® Low Profile Implant | 7.5 mm x 190 mm | CURVAFIX, INC. | HWC | 10850070500354 |
| Sterilization Tray, Lower | CIT-002-LP | CURVAFIX, INC. | HWC | 10850070500668 |
| Sterilization Tray, Outer | CIC-003-LP | CURVAFIX, INC. | HWC | 10850070500644 |
| 7.5mm CurvaFix Easy Out | CEO-003-LP | CURVAFIX, INC. | HWC | 10850070500590 |
| 9.5mm CurvaFix Inserter | CIA-002-LP | CURVAFIX, INC. | HWC | 10850070500514 |
| CurvaFix® Low Profile Implant | 7.5 mm x 210 mm | CURVAFIX, INC. | HWC | 10850070500378 |
| CurvaFix® Low Profile Implant | 9.5 mm x 140 mm | CURVAFIX, INC. | HWC | 10850070500170 |
| CurvaFix® Low Profile Implant | 9.5 mm x 120 mm | CURVAFIX, INC. | HWC | 10850070500156 |
| CurvaFix® Low Profile Implant | 7.5 mm x 160 mm | CURVAFIX, INC. | HWC | 10850070500323 |
| CurvaFix® Low Profile Implant | 7.5 mm x 110 mm | CURVAFIX, INC. | HWC | 10850070500279 |
| CurvaFix® Low Profile Implant | 9.5 mm x 90 mm | CURVAFIX, INC. | HWC | 10850070500125 |
| CurvaFix® Low Profile Implant | 7.5 mm x 200 mm | CURVAFIX, INC. | HWC | 10850070500361 |
| CurvaFix® Low Profile Implant | 7.5 mm x 180 mm | CURVAFIX, INC. | HWC | 10850070500347 |
| CurvaFix® Low Profile Implant | 9.5 mm x 200 mm | CURVAFIX, INC. | HWC | 10850070500231 |
| Sterilization Tray, Upper | CIT-001-LP | CURVAFIX, INC. | HWC | 10850070500651 |
| CurvaFix® Low Profile Implant | 9.5 mm x 160 mm | CURVAFIX, INC. | HWC | 10850070500194 |
| CurvaFix® Low Profile Implant | 9.5 mm x 110 mm | CURVAFIX, INC. | HWC | 10850070500149 |