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510(k) K161292

Distal Radius Plating System by Miami Device Solutions, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2016
Date Received
May 9, 2016
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 Miami Device Solutions, LLC

  • K182810 — Distal Radius Plating System (December 10, 2018)
  • K172786 — MDS Plating System (December 8, 2017)
  • K162898 — Olecranon Plating System (March 17, 2017)
  • K162635 — Distal Radius Plating System (October 21, 2016)
  • K161058 — Cannulated Screw (July 29, 2016)
  • K141493 — PROXIMAL HUMERUS PLATING SYSTEM (March 20, 2015)

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