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510(k) K982875

MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM by Danek Medical, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1999
Date Received
August 14, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Danek Medical, Inc.

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  • K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (December 15, 1999)
  • K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR (May 28, 1999)
  • K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM (March 10, 1999)
  • K984522 — MODIFICATION OF TSRH SPINAL SYSTEM (January 6, 1999)
  • K982154 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (July 13, 1998)
  • K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM (March 20, 1998)
  • K943827 — SPINE FIXATION (February 14, 1996)
  • K943356 — INCLUSIVE ENDOSCOPE (May 10, 1995)

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