Home / 510(k) Clearances / K810554

510(k) K810554

LUMBAR FLEXION BRACE by Orthomedics — Product Code IPY

K810554 is an FDA 510(k) premarket notification submitted by Orthomedics for the device "LUMBAR FLEXION BRACE". The FDA issued a decision of Substantially Equivalent on March 13, 1981. The device falls under product code IPY (Orthosis, Lumbo-Sacral), a Class I device regulated under 21 CFR 890.3490. Orthomedics has at least 10 other 510(k) clearances on record.

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, Lumbo-Sacral
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Orthomedics

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K832742 — EXTENSION CONTROL KNEE 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)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (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 IPY

  • K823882 — M-BRACE (January 17, 1983)
  • K823823 — LUMBOSACRAL SUPPORT (January 14, 1983)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K812099 — CASH ORTHOSIS (August 13, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)
  • K803033 — CRUSADER HYPEREXTENSION BRACE (December 22, 1980)
  • K801712 — LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC (August 7, 1980)
  • K792269 — WRIGHT DOW CORNING SOFTGOODS W/DOW (February 5, 1980)
  • K791314 — VERTEBRACE SPINAL SUPPORTS (July 30, 1979)

FDA data resources