Orthomedics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K832741JASON CERVICAL ORTHOSISSeptember 20, 1983
K832740FEMORAL FRACTURE ORTHOSISSeptember 20, 1983
K832742EXTENSION CONTROL KNEE ORTHOSISSeptember 20, 1983
K811456ORTHO-FRAC KITJune 12, 1981
K811298EXECUTIVE COLLARMay 27, 1981
K811297CERVICAL SUPPORTMay 27, 1981
K810554LUMBAR FLEXION BRACEMarch 13, 1981
K810557HIP ABDUCTION SPLINTMarch 13, 1981
K810555SCOLIOSIS ORTHOTIC SYSTEMMarch 13, 1981
K810556SPINAL EXTENSION BRACEMarch 13, 1981
K802910PLASTIC FRACTURE CAST BRACE KNEE JOINTDecember 22, 1980
K803033CRUSADER HYPEREXTENSION BRACEDecember 22, 1980
K802908ULNAR FRACTURE BRACEDecember 17, 1980
K802911A/K SOCKETDecember 17, 1980
K802909HUMERAL FRACTURE BRACEDecember 17, 1980
K802871TIBIAL FRACTURE BRACEDecember 11, 1980