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510(k) K182810

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2018
Date Received
October 3, 2018
Clearance Type
Special
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

  • K172786 — MDS Plating System (December 8, 2017)
  • K162898 — Olecranon Plating System (March 17, 2017)
  • K162635 — Distal Radius Plating System (October 21, 2016)
  • K161292 — Distal Radius Plating System (August 15, 2016)
  • K161058 — Cannulated Screw (July 29, 2016)
  • K141493 — PROXIMAL HUMERUS PLATING SYSTEM (March 20, 2015)

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