510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181362Substantially Equivalent

TEMA Elbow System

Lima Corporate S.p.A., Villanova Di San Daniele Del Friuli, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181362 is the FDA 510(k) clearance record for TEMA Elbow System, a class II device, cleared for Lima Corporate S.P.A. on under FDA product code JDC (Prosthesis, Elbow, Constrained, Cemented). FDA records list 64 510(k) clearances for Lima Corporate S.P.A., from to . As of , FDA records show one recall naming K181362.

Clearance record

Decision date
Received
(269 days to decision)
Product code
JDC Prosthesis, Elbow, Constrained, Cemented
Regulation
21 CFR 888.3150
Device class
Class II
Review panel
Orthopedic
Applicant
Lima Corporate S.P.A. Via Nazionale 52, Villanova Di San Daniele Del Friuli, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDC

Trailing 12 months

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

FDA records show no clearances under product code JDC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDC, 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