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510(k) K832742

EXTENSION CONTROL KNEE ORTHOSIS by Orthomedics — Product Code ITM

K832742 is an FDA 510(k) premarket notification submitted by Orthomedics for the device "EXTENSION CONTROL KNEE ORTHOSIS". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code ITM (Cage, Knee), a Class I device regulated under 21 CFR 890.3475. 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

Device Classification

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

Other clearances by Orthomedics

  • K832740 — FEMORAL FRACTURE ORTHOSIS (September 20, 1983)
  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K811456 — ORTHO-FRAC KIT (June 12, 1981)
  • K811298 — EXECUTIVE COLLAR (May 27, 1981)
  • K811297 — CERVICAL SUPPORT (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)

Other clearances for product code ITM

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

FDA data resources