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510(k) K832742

EXTENSION CONTROL KNEE ORTHOSIS by Orthomedics — Product Code ITM

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

Device Classification

Device Name
Cage, Knee
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Orthomedics

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K832740 — FEMORAL FRACTURE ORTHOSIS (September 20, 1983)
  • K811456 — ORTHO-FRAC KIT (June 12, 1981)
  • K811298 — EXECUTIVE COLLAR (May 27, 1981)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K810554 — LUMBAR FLEXION BRACE (March 13, 1981)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (March 13, 1981)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)
  • K802910 — PLASTIC FRACTURE CAST BRACE KNEE JOINT (December 22, 1980)

Other clearances for product code ITM

  • K812064 — POLI-AXIAL KNEE CAGE (August 13, 1981)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K770900 — CAST BRWM, FRACTURE (July 21, 1977)
  • K760573 — IMPROVED KNEE DRESSING (October 5, 1976)