510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043048Substantially Equivalent

Grafton Plus Dbm Paste

Osteotech Inc, Eatontown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043048 is the FDA 510(k) clearance record for GRAFTON PLUS DBM PASTE, a class II device, cleared for Osteotech, Inc. on under FDA product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)). FDA records list 24 510(k) clearances for Osteotech, Inc., from to . As of , FDA records show 14 recalls naming K043048.

Clearance record

Decision date
Received
(384 days to decision)
Product code
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Osteotech, Inc. 51 James Way, Eatontown NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBP

Trailing 12 months

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

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