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510(k) K884561

KOENIG TOTAL TOE IMPLANT by Dow Corning Wright — Product Code LZJ

K884561 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "KOENIG TOTAL TOE IMPLANT". The FDA issued a decision of SN on January 24, 1989. The device falls under product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained), a Class U device. Dow Corning Wright has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 24, 1989
Date Received
October 31, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device Class
Class U
Regulation Number
Review Panel
OR
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 LZJ

  • K132496 — ARTHROSURFACE TOEMOTION (February 26, 2014)
  • K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (December 21, 2010)
  • K072251 — MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (May 8, 2008)
  • K950864 — GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (July 31, 1995)
  • K941650 — TOTAL TOE SYSTEM II (December 19, 1994)
  • K924724 — KINETIK GREAT TOE SYSTEM (January 5, 1994)
  • K922211 — OSTEOMED GREAT TOE SYSTEM (November 9, 1993)
  • K920446 — TOTAL TOE SYSTEM (March 22, 1993)
  • K920667 — GREAT TOE IMPLANT (June 19, 1992)
  • K911552 — ANATOMIC TOE SYSTEM (June 28, 1991)

FDA data resources