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510(k) K094037

TC PLATING SYSTEM by Ortho-Pro, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2010
Date Received
December 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Ortho-Pro, LLC

  • K102601 — ORTHOFLEX ROD (January 14, 2011)
  • K042310 — ORTHO-PRO CANNULATED BONE SCREWS (September 16, 2004)
  • K032682 — STS SCREW (October 22, 2003)

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