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510(k) K031318

TRAXIS CEMENT RESTRICTOR by Spinal Concepts, Inc. — Product Code JDK

K031318 is an FDA 510(k) premarket notification submitted by Spinal Concepts, Inc. for the device "TRAXIS CEMENT RESTRICTOR". The FDA issued a decision of SESU on August 22, 2003. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Spinal Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
August 22, 2003
Date Received
April 25, 2003
Clearance Type
Special
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 Spinal Concepts, Inc.

  • K051000 — FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE (May 19, 2005)
  • K050706 — HARMONY PORT SYSTEM, MODEL 1907 SERIES (April 15, 2005)
  • K040096 — SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM (July 1, 2004)
  • K033663 — SPINAL CONCEPTS INC. CODA (May 27, 2004)
  • K033517 — SPINAL CONCEPTS INC. CADENCE AND TRAXIS (February 18, 2004)
  • K031855 — SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM (September 17, 2003)
  • K031985 — SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM (September 11, 2003)
  • K031672 — SPINAL CONCEPTS, INC. INFIX SYSTEM (August 7, 2003)
  • K031837 — MODIFICATION TO FORTITUDE CEMENT RESTRICTOR (July 24, 2003)
  • K030087 — SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM (July 17, 2003)

Other clearances for product code JDK

  • K210062 — Mectaplug PE II (April 8, 2021)
  • K061465 — KMI CEMENT RESTRICTOR IMPLANT (October 5, 2006)
  • 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)

FDA data resources