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510(k) K911307

CROSSLINK PLATE by Danek Medical, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1991
Date Received
March 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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  • 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)

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