510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840242Substantially Equivalent

Poly Plug Cement Restrictor

Latham Manufacturer, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840242 is the FDA 510(k) clearance record for POLY PLUG CEMENT RESTRICTOR, a class II device, cleared for Latham Manufacturer on under FDA product code JDS (Nail, Fixation, Bone). FDA records list one 510(k) clearance for Latham Manufacturer. As of , FDA records show no recalls naming K840242.

Clearance record

Decision date
Received
(131 days to decision)
Product code
JDS Nail, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Latham Manufacturer 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JDS

Trailing 12 months

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

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