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
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K080329Substantially Equivalent

Cap Plus, Equivabone, Cap/dbm

Etex Corp., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080329 is the FDA 510(k) clearance record for CAP PLUS, EQUIVABONE, CAP/DBM, a class II device, cleared for Etex Corp. on under FDA product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)). FDA records list 24 510(k) clearances for Etex Corp., from to . As of , FDA records show no recalls naming K080329.

Clearance record

Decision date
Received
(81 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
Etex Corp. 38 Sidney St., 3flr, Cambridge MA
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