510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033395Substantially Equivalent

Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

Cerenovus, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033395 is the FDA 510(k) clearance record for CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code GXO (Strip, Craniosynostosis, Preformed). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K033395.

Clearance record

Decision date
Received
(125 days to decision)
Product code
GXO Strip, Craniosynostosis, Preformed
Regulation
21 CFR 882.5900
Device class
Class II
Review panel
Neurology
Applicant
Codman & Shurtleff, Inc. 325 Paramount Dr., Raynham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXO

Trailing 12 months

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

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