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510(k) K792269

WRIGHT DOW CORNING SOFTGOODS W/DOW by Dow Corning Wright — Product Code IPY

K792269 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "WRIGHT DOW CORNING SOFTGOODS W/DOW". The FDA issued a decision of Substantially Equivalent on February 5, 1980. The device falls under product code IPY (Orthosis, Lumbo-Sacral), a Class I device regulated under 21 CFR 890.3490. Dow Corning Wright has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1980
Date Received
November 9, 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 by Dow Corning Wright

  • K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT (September 7, 1994)
  • K932911 — ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT (June 30, 1994)
  • K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT (June 3, 1994)
  • K932222 — SLT FEMORAL HEAD (May 27, 1994)
  • K932858 — ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT (February 16, 1994)
  • K930228 — ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE (November 30, 1993)
  • K925900 — LACEY REVISION FEMORAL COMPONENT (August 24, 1993)
  • K930189 — ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP (August 6, 1993)
  • K930188 — ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT (August 3, 1993)
  • K930190 — ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP (August 2, 1993)

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)
  • 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)
  • K791314 — VERTEBRACE SPINAL SUPPORTS (July 30, 1979)

FDA data resources