Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K233154
SkyOPS Orthopedic Plate System · Sky Surgical, LLC · decided 2023-12-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SkyOPS | S0014 | Sky Surgical, LLC | KCT | 00850024702318 |
| SkyOPS | 24-024-N | Sky Surgical, LLC | HWC | 00850024702134 |
| SkyOPS | S0009 | Sky Surgical, LLC | KCT | 00850024702530 |
| SkyOPS | 24-014-L | Sky Surgical, LLC | HWC | 00850024702202 |
| SkyOPS | S0021 | Sky Surgical, LLC | KCT | 00850024702561 |
| SkyOPS | 24-022-N | Sky Surgical, LLC | HWC | 00850024702127 |
| SkyOPS | 001-2-11-R | Sky Surgical, LLC | HWR | 00850024702493 |
| SkyOPS | 24-018-N | Sky Surgical, LLC | HWC | 00850024702103 |
| SkyOPS | 24-026-N | Sky Surgical, LLC | HWC | 00850024702141 |
| SkyOPS | 24-030-L | Sky Surgical, LLC | HWC | 00850024702288 |
| SkyOPS | 24-024-L | Sky Surgical, LLC | HWC | 00850024702257 |
| SkyOPS | 24-020-N | Sky Surgical, LLC | HWC | 00850024702110 |
| SkyOPS | S0010 | Sky Surgical, LLC | KCT | 00850024702547 |
| SkyOPS | 001-2-09 | Sky Surgical, LLC | HWR | 00850024702356 |
| SkyOPS | P0002 | Sky Surgical, LLC | HRS | 00850024702028 |
| SkyOPS | 24-022-L | Sky Surgical, LLC | HWC | 00850024702240 |
| SkyOPS | 001-2-10-L | Sky Surgical, LLC | HWR | 00850024702462 |
| SkyOPS | 24-030-N | Sky Surgical, LLC | HWC | 00850024702165 |
| SkyOPS | 001-2-04-L | Sky Surgical, LLC | HWR | 00850024702349 |
| SkyOPS | 24-014-N | Sky Surgical, LLC | HWC | 00850024702080 |
| SkyOPS | 24-028-N | Sky Surgical, LLC | HWC | 00850024702158 |
| SkyOPS | P0003L | Sky Surgical, LLC | HRS | 00850024702035 |
| SkyOPS | P0001L | Sky Surgical, LLC | HRS | 00850024702004 |
| SkyOPS | 24-008-N | Sky Surgical, LLC | HWC | 00850024702059 |
| SkyOPS | S0004 | Sky Surgical, LLC | KCT | 00850024702516 |