510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831128Substantially Equivalent

Bard Intramedullary Plug

C.R. Bard Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831128 is the FDA 510(k) clearance record for BARD INTRAMEDULLARY PLUG, a class II device, cleared for C.R. Bard, Inc. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K831128.

Clearance record

Decision date
Received
(97 days to decision)
Product code
JDK Prosthesis, Hip, Cement Restrictor
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
C.R. Bard, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JDK

Trailing 12 months

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

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