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510(k) K070178

AESCULAP RESORBABLE PIN, MODEL FR735 by Aesculap Implant System, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2007
Date Received
January 19, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Aesculap Implant System, Inc.

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  • K133802 — AIS MODULIFT VBR SYSTEM (April 17, 2014)
  • K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (October 30, 2013)
  • K130887 — S4C NAVIGATION INSTRUMENTS (August 13, 2013)
  • K123909 — AESCULAP CESPACE XP (April 15, 2013)
  • K130291 — S4 SPINAL SYSTEM (April 11, 2013)
  • K122985 — COLUMBUS REVISION KNEE SYSTEM (October 26, 2012)
  • K112551 — S4 SPINAL SYSTEM (November 21, 2011)
  • K101281 — VEGA KNEE SYSTEM (July 30, 2010)

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