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510(k) K810555

SCOLIOSIS ORTHOTIC SYSTEM by Orthomedics — Product Code IQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1981
Date Received
March 2, 1981
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

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K832740 — FEMORAL FRACTURE ORTHOSIS (September 20, 1983)
  • K832742 — EXTENSION CONTROL KNEE 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)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)
  • K803033 — CRUSADER HYPEREXTENSION BRACE (December 22, 1980)

Other clearances for product code IQF

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K812342 — ZEE EXTRICATION DEVICE (September 21, 1981)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K791350 — POPE AMBULATORY HALO VEST (August 3, 1979)
  • K781761 — KENDRICK EXTRICATION DEVICE (October 27, 1978)
  • K780489 — SPINE BOARD (April 12, 1978)