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510(k) K033663

SPINAL CONCEPTS INC. CODA by Spinal Concepts, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2004
Date Received
November 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
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)
  • 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)
  • K031318 — TRAXIS CEMENT RESTRICTOR (August 22, 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)

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