510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K972760Substantially Equivalent

Link, Acetabular Revision Mesh Cup

Link America, Inc., Denville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972760 is the FDA 510(k) clearance record for LINK, ACETABULAR REVISION MESH CUP, a class II device, cleared for Link America, Inc. on under FDA product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis). FDA records list 21 510(k) clearances for Link America, Inc., from to . As of , FDA records show no recalls naming K972760.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Link America, Inc. 321 Palmer Rd., Denville NJ
510(k) summary
Statement
Third party review
No

Clearances, product code JDJ

Trailing 12 months

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

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