510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954717Substantially Equivalent

Sodem High Speed System for Neurosurgery & Median Sternotomy

Sodem Diffusion SA, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954717 is the FDA 510(k) clearance record for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY, a class II device, cleared for Sodem Diffusion SA on under FDA product code HBB (Motor, Drill, Pneumatic). FDA records list 3 510(k) clearances for Sodem Diffusion SA, from to . As of , FDA records show no recalls naming K954717.

Clearance record

Decision date
Received
(467 days to decision)
Product code
HBB Motor, Drill, Pneumatic
Regulation
21 CFR 882.4370
Device class
Class II
Review panel
Neurology
Applicant
Sodem Diffusion SA 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code HBB

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