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510(k) K161292

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

K161292 is an FDA 510(k) premarket notification submitted by Miami Device Solutions, LLC for the device "Distal Radius Plating System". The FDA issued a decision of Substantially Equivalent on August 15, 2016. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Miami Device Solutions, LLC has at least 6 other 510(k) clearances on record.

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)

Other clearances for product code HRS

  • K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM (August 13, 2026)
  • K261511 — Xpert Ankle (July 28, 2026)
  • K261406 — Versalock Proximal Tibial Plating System (July 21, 2026)
  • K262032 — TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fus (July 16, 2026)
  • K261191 — Alians Elbow S (July 8, 2026)
  • K261054 — RibPlate System (July 1, 2026)
  • K261351 — SALGINA 2.5mm Distal Radius System (June 26, 2026)
  • K260958 — I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with An (June 16, 2026)
  • K261207 — Exalta Proximal Tibia Plating System (June 12, 2026)
  • K260761 — APTUS Clavicle System 2.8 (June 5, 2026)

FDA data resources