510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K073229Substantially Equivalent

Nerve Monitoring Cable

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette MI / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073229 is the FDA 510(k) clearance record for NERVE MONITORING CABLE, a class II device, cleared for Pioneer Surgical Technology on under FDA product code GXZ (Electrode, Needle). FDA records list 100 510(k) clearances for RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), from to . As of , FDA records show no recalls naming K073229.

Clearance record

Decision date
Received
(204 days to decision)
Product code
GXZ Electrode, Needle
Regulation
21 CFR 882.1350
Device class
Class II
Review panel
Neurology
Applicant
Pioneer Surgical Technology 375 River Park Cir., Marquette MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXZ

Trailing 12 months

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

FDA records show no clearances under product code GXZ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260