510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091193Substantially Equivalent

Accell Evo3c

IsoTis OrthoBiologics, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091193 is the FDA 510(k) clearance record for ACCELL EVO3C, a class II device, cleared for Isotis Orthobiologics, Inc. on under FDA product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)). FDA records list 10 510(k) clearances for Isotis Orthobiologics, Inc., from to . As of , FDA records show one recall naming K091193.

Clearance record

Decision date
Received
(109 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
Isotis Orthobiologics, Inc. 2 Goodyear, Suite A, Irvine CA
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