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510(k) K810557

HIP ABDUCTION SPLINT by Orthomedics — Product Code IOZ

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
Splint, Abduction, Congenital Hip Dislocation
Device Class
Class I
Regulation Number
890.3665
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)
  • 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 IOZ

  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K823820 — ABDUCTION PILLOW (January 14, 1983)
  • K780375 — PAVLIK HARNESS (March 15, 1978)