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510(k) K040197

EAGLE ANTERIOR CERVIAL PLATE SYSTEM by Depuyacromed — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2004
Date Received
January 29, 2004
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

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  • K021039 — BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (December 11, 2002)
  • K023438 — MODIFICATION TO MONARCH SPINE SYSTEM (November 13, 2002)

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