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510(k) K140625

ORTHOSORB LS by Biomet, Inc. — Product Code OVZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2014
Date Received
March 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Resorbable, Hard Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.

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Other clearances for product code OVZ

  • K111077 — ORTHOSORB RESORBABLE PINS (July 12, 2011)
  • K901456 — ORTHOSORB(R) ABSORBABLE PIN (August 15, 1990)