510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013755Substantially Equivalent

Concert Radiopaque Bone Cement

Immedica, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013755 is the FDA 510(k) clearance record for CONCERT RADIOPAQUE BONE CEMENT, a class II device, cleared for Immedica, Inc. on under FDA product code LOD (Bone Cement). FDA records list 8 510(k) clearances for Immedica, Inc., from to . As of , FDA records show no recalls naming K013755.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LOD Bone Cement
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Immedica, Inc. 615 7th St. NE, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code LOD

Trailing 12 months
1 clearance under product code LOD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260