510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130497Substantially Equivalent

D4000 Drive System; D4000a Drive System with Irrigation

Linvatec Corporation D/B/A Conmed Linvatec, Largo FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130497 is the FDA 510(k) clearance record for D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION, a class II device, cleared for Linvatec Corporation D/B/A Conmed Linvatec on under FDA product code HBC (Motor, Drill, Electric). FDA records list 4 510(k) clearances for Linvatec Corporation D/B/A Conmed Linvatec, from to . As of , FDA records show no recalls naming K130497.

Clearance record

Decision date
Received
(31 days to decision)
Product code
HBC Motor, Drill, Electric
Regulation
21 CFR 882.4360
Device class
Class II
Review panel
Neurology
Applicant
Linvatec Corporation D/B/A Conmed Linvatec 11311 Concept Blvd., Largo FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBC

Trailing 12 months
1 clearance under product code HBC 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 HBC, 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