510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051642Substantially Equivalent

Fr.o.h. Calcaneus Repair System

I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051642 is the FDA 510(k) clearance record for FR.O.H. CALCANEUS REPAIR SYSTEM, a class II device, cleared for I.T.S. Implantat-Technologie-Systeme GmbH on under FDA product code NDF (Plate, Fixation, Bone, Non-Spinal, Metallic). FDA records list 13 510(k) clearances for I.T.S. Implantat-Technologie-Systeme GmbH, from to . As of , FDA records show one recall naming K051642.

Clearance record

Decision date
Received
(63 days to decision)
Product code
NDF Plate, Fixation, Bone, Non-Spinal, Metallic
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
I.T.S. Implantat-Technologie-Systeme GmbH 3150 E. 200th. St., Prior Lake MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDF

Trailing 12 months

FDA records hold no clearances under product code NDF in the trailing twelve months.

FDA records show no clearances under product code NDF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NDF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260