510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K926116Substantially Equivalent

Codman Sofwire(tm) Kit

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

K926116 is the FDA 510(k) clearance record for CODMAN SOFWIRE(TM) KIT, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K926116.

Clearance record

Decision date
Received
(117 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
510(k) summary
Summary
Third party review
No

Clearances, product code JDQ

Trailing 12 months
1 clearance under product code JDQ in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260