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510(k) K832740

FEMORAL FRACTURE ORTHOSIS by Orthomedics

K832740 is an FDA 510(k) premarket notification submitted by Orthomedics for the device "FEMORAL FRACTURE ORTHOSIS". The FDA issued a decision of Substantially Equivalent on September 20, 1983. Orthomedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
August 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Orthomedics

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K832742 — EXTENSION CONTROL KNEE ORTHOSIS (September 20, 1983)
  • K811456 — ORTHO-FRAC KIT (June 12, 1981)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K811298 — EXECUTIVE COLLAR (May 27, 1981)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (March 13, 1981)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)
  • K810554 — LUMBAR FLEXION BRACE (March 13, 1981)
  • K803033 — CRUSADER HYPEREXTENSION BRACE (December 22, 1980)

FDA data resources