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510(k) K153306

Imbibe Needle by Orthovita, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2015
Date Received
November 16, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Orthovita, Inc.

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  • K103173 — VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE (February 7, 2011)
  • K101171 — ORTHOVITA PEEK SPACER (January 25, 2011)
  • K102545 — FM-02 BONE GRAFT SUBSTITUTE (October 27, 2010)
  • K091618 — VITOMATRIX (September 27, 2010)
  • K080108 — CORTOSS BONE AUGMENTATION MATERIAL (June 5, 2009)

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