510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910128Substantially Equivalent

Levtech Titanium Bone Wire

Levtech, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910128 is the FDA 510(k) clearance record for LEVTECH TITANIUM BONE WIRE, a class II device, cleared for Levtech, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 5 510(k) clearances for Levtech, Inc., from to . As of , FDA records show no recalls naming K910128.

Clearance record

Decision date
Received
(160 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Levtech, Inc. P.O. Box 516, Jacksonville FL
Third party review
No

Clearances, product code JDQ

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