510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K003549Substantially Equivalent

Codman Craniosorb Absorbable Fixation System Purple Rivets

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

K003549 is the FDA 510(k) clearance record for CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code JEY (Plate, Bone). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K003549.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Codman & Shurtleff, Inc. 325 Paramount Dr., Raynham MA
510(k) summary
Summary
Third party review
No

Clearances, product code JEY

Trailing 12 months
4 clearances under product code JEY in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260