510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080434Substantially Equivalent

Intertan Chs Locking Plate System Prox Fem Plates/screw

Smith & Nephew, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080434 is the FDA 510(k) clearance record for INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code JDO (Device, Fixation, Proximal Femoral, Implant). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K080434.

Clearance record

Decision date
Received
(51 days to decision)
Product code
JDO Device, Fixation, Proximal Femoral, Implant
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Smith & Nephew, Inc. 1450 Brooks Rd., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDO

Trailing 12 months

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

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