510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K902517Substantially Equivalent

Neurosurgical Headframe Accessories

Sims Surgical, Inc., Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902517 is the FDA 510(k) clearance record for NEUROSURGICAL HEADFRAME ACCESSORIES, a class II device, cleared for Sims Surgical, Inc. on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 3 510(k) clearances for Sims Surgical, Inc., from to . As of , FDA records show no recalls naming K902517.

Clearance record

Decision date
Received
(26 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Sims Surgical, Inc. 15 Kit St., Keene NH
Third party review
No

Clearances, product code GZT

Trailing 12 months
1 clearance under product code GZT in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZT, 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 20261
October 20260