510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K051945Substantially Equivalent

Miot Plating System

Orthofix SRL, Wilmington NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051945 is the FDA 510(k) clearance record for MIOT PLATING SYSTEM, a class II device, cleared for Orthofix Srl on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 102 510(k) clearances for Orthofix Srl, from to . As of , FDA records show no recalls naming K051945.

Clearance record

Decision date
Received
(50 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Orthofix Srl 632 Dundee Dr., Wilmington NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRS

Trailing 12 months
57 clearances under product code HRS in the twelve months to November 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20264
November 20260