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510(k) K924724

KINETIK GREAT TOE SYSTEM by Kinetikos Medical, Inc. — Product Code LZJ

K924724 is an FDA 510(k) premarket notification submitted by Kinetikos Medical, Inc. for the device "KINETIK GREAT TOE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 5, 1994. The device falls under product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained), a Class U device. Kinetikos Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1994
Date Received
September 21, 1992
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 Kinetikos Medical, Inc.

  • K061749 — ECLIPSE TOTAL ANKLE IMPLANT (November 22, 2006)
  • K061465 — KMI CEMENT RESTRICTOR IMPLANT (October 5, 2006)
  • K051611 — MBARESORB IMPLANT (September 6, 2005)
  • K041461 — KMI DISTAL VOLAR RADIUS PLATE SYSTEM (August 16, 2004)
  • K032806 — KATALYST RADIAL HEAD IMPLANT (April 16, 2004)
  • K040356 — KOMPRESSOR SCREW SYSTEM (March 1, 2004)
  • K024233 — KOMPRESSOR SCREW SYSTEM (February 6, 2003)
  • K030037 — UNIVERSAL TOTAL WRIST SYSTEM (February 5, 2003)
  • K023770 — K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) (December 12, 2002)
  • K020554 — MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM (May 3, 2002)

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)
  • 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)
  • K884561 — KOENIG TOTAL TOE IMPLANT (January 24, 1989)

FDA data resources