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510(k) K150621

OsteoSelect PLUS Demineralized Bone Matrix Putty by Bacterin International, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2015
Date Received
March 11, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Bacterin International, Inc.

  • K130498 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (May 31, 2013)
  • K091321 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (September 11, 2009)
  • K063245 — ELUTIA COATED CLOSED SURGICAL WOUND DRAIN (November 28, 2007)

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