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510(k) K061465

KMI CEMENT RESTRICTOR IMPLANT by Kinetikos Medical, Inc. — Product Code JDK

K061465 is an FDA 510(k) premarket notification submitted by Kinetikos Medical, Inc. for the device "KMI CEMENT RESTRICTOR IMPLANT". The FDA issued a decision of SESU on October 5, 2006. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Kinetikos Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
October 5, 2006
Date Received
May 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Cement Restrictor
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Kinetikos Medical, Inc.

  • K061749 — ECLIPSE TOTAL ANKLE IMPLANT (November 22, 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)
  • K991873 — KMI WRIST FUSION SYSTEM (August 17, 1999)

Other clearances for product code JDK

  • K210062 — Mectaplug PE II (April 8, 2021)
  • K061698 — MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR (July 12, 2006)
  • K060247 — LIFE SPINE CEMENT RESTRICTOR (May 11, 2006)
  • K060132 — SPINAL USA CEMENT RESTRICTOR SYSTEM (March 16, 2006)
  • K051371 — INTERBODY INNOVATIONS CEMENT RESTRICTOR (December 6, 2005)
  • K051836 — SKELITE RESORBABLE CEMENT RESTRICTOR (November 21, 2005)
  • K051607 — NOVASPINE CEMENT RESTRICTOR NSCR (October 7, 2005)
  • K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 2005)
  • K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (June 17, 2005)
  • K050699 — MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 (April 15, 2005)

FDA data resources