510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K234008Substantially Equivalent

Cerament G

Bonesupport Inc, Lund, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K234008 is the FDA 510(k) clearance record for CERAMENT G, a class II device, cleared for Bonesupport AB on under FDA product code QRR (Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside). FDA's definition for product code QRR reads: "A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to...". FDA records list 7 510(k) clearances for Bonesupport AB, from to . As of , FDA records show no recalls naming K234008.

Clearance record

Decision date
Received
(85 days to decision)
Product code
QRR Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Regulation
21 CFR 888.3046
Device class
Class II
Review panel
Orthopedic
Applicant
Bonesupport AB Scheelevagen 19 Ideon Science Park, Lund, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRR

Trailing 12 months

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

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