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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)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SkyOPSS0014Sky Surgical, LLCKCT00850024702318
SkyOPS24-024-NSky Surgical, LLCHWC00850024702134
SkyOPSS0009Sky Surgical, LLCKCT00850024702530
SkyOPS24-014-LSky Surgical, LLCHWC00850024702202
SkyOPSS0021Sky Surgical, LLCKCT00850024702561
SkyOPS24-022-NSky Surgical, LLCHWC00850024702127
SkyOPS001-2-11-RSky Surgical, LLCHWR00850024702493
SkyOPS24-018-NSky Surgical, LLCHWC00850024702103
SkyOPS24-026-NSky Surgical, LLCHWC00850024702141
SkyOPS24-030-LSky Surgical, LLCHWC00850024702288
SkyOPS24-024-LSky Surgical, LLCHWC00850024702257
SkyOPS24-020-NSky Surgical, LLCHWC00850024702110
SkyOPSS0010Sky Surgical, LLCKCT00850024702547
SkyOPS001-2-09Sky Surgical, LLCHWR00850024702356
SkyOPSP0002Sky Surgical, LLCHRS00850024702028
SkyOPS24-022-LSky Surgical, LLCHWC00850024702240
SkyOPS001-2-10-LSky Surgical, LLCHWR00850024702462
SkyOPS24-030-NSky Surgical, LLCHWC00850024702165
SkyOPS001-2-04-LSky Surgical, LLCHWR00850024702349
SkyOPS24-014-NSky Surgical, LLCHWC00850024702080
SkyOPS24-028-NSky Surgical, LLCHWC00850024702158
SkyOPSP0003L Sky Surgical, LLCHRS00850024702035
SkyOPSP0001LSky Surgical, LLCHRS00850024702004
SkyOPS24-008-NSky Surgical, LLCHWC00850024702059
SkyOPSS0004Sky Surgical, LLCKCT00850024702516