510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911918Substantially Equivalent

Swivel Horseshoe Headrest

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

K911918 is the FDA 510(k) clearance record for SWIVEL HORSESHOE HEADREST, a class I device, cleared for Codman & Shurtleff, Inc. on under FDA product code HBM (Headrest, Neurosurgical). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K911918.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HBM Headrest, Neurosurgical
Regulation
21 CFR 882.4440
Device class
Class I
Review panel
Neurology
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
510(k) summary
Statement
Third party review
No

Clearances, product code HBM

Trailing 12 months

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

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