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510(k) K023835

DEVEX MESH SYSTEM by Depuyacromed — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2003
Date Received
November 18, 2002
Clearance Type
Special
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 Depuyacromed

  • K040197 — EAGLE ANTERIOR CERVIAL PLATE SYSTEM (April 2, 2004)
  • K031635 — DEPUY ACROMED VBR SYSTEM (June 23, 2003)
  • K030833 — DEPUY ACROMED VBR SYSTEM (April 10, 2003)
  • K030383 — MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS (February 26, 2003)
  • K030249 — SURGICAL TITANIUM MESH SYSTEM (February 14, 2003)
  • K030103 — SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS (February 5, 2003)
  • K024348 — MONARCH SPINE SYSTEM (January 28, 2003)
  • K023804 — MOSS MIAMI SPINAL SYSTEM PIN NUT (January 23, 2003)
  • K021039 — BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (December 11, 2002)
  • K023438 — MODIFICATION TO MONARCH SPINE SYSTEM (November 13, 2002)

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