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510(k) K832741

JASON CERVICAL ORTHOSIS by Orthomedics — Product Code IQF

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
Orthosis, Cervical-Thoracic, Rigid
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Orthomedics

  • K832740 — FEMORAL FRACTURE 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)
  • 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 IQF

  • K812342 — ZEE EXTRICATION DEVICE (September 21, 1981)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (March 13, 1981)
  • K791350 — POPE AMBULATORY HALO VEST (August 3, 1979)
  • K781761 — KENDRICK EXTRICATION DEVICE (October 27, 1978)
  • K780489 — SPINE BOARD (April 12, 1978)