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510(k) K812422

CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS by Surgical Appliance Industries, Inc. — Product Code IPY

K812422 is an FDA 510(k) premarket notification submitted by Surgical Appliance Industries, Inc. for the device "CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS". The FDA issued a decision of Substantially Equivalent on September 14, 1981. The device falls under product code IPY (Orthosis, Lumbo-Sacral), a Class I device regulated under 21 CFR 890.3490. Surgical Appliance Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1981
Date Received
August 24, 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 Surgical Appliance Industries, Inc.

  • K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION G (April 27, 2012)
  • K821682 — TRUNCAL ORTHOSIS (June 24, 1982)
  • K813416 — EXTERNAL BREAST PROSTHESIS (January 18, 1982)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K811690 — ANKLE-FOOT CAST/SPLINT (June 25, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)

Other clearances for product code IPY

  • K823882 — M-BRACE (January 17, 1983)
  • K823823 — LUMBOSACRAL SUPPORT (January 14, 1983)
  • K812099 — CASH ORTHOSIS (August 13, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)
  • K810554 — LUMBAR FLEXION BRACE (March 13, 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