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510(k) K791314

VERTEBRACE SPINAL SUPPORTS by Vertebrace, Inc. — Product Code IPY

K791314 is an FDA 510(k) premarket notification submitted by Vertebrace, Inc. for the device "VERTEBRACE SPINAL SUPPORTS". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code IPY (Orthosis, Lumbo-Sacral), a Class I device regulated under 21 CFR 890.3490.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
July 16, 1979
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 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)
  • K810554 — LUMBAR FLEXION 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)

FDA data resources