510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862523Substantially Equivalent

Man Surg Instr/access Dumbach Titan Mesh Impl Sys

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

K862523 is the FDA 510(k) clearance record for MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS, a class I device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code EKW (Broach, Endodontic). FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K862523.

Clearance record

Decision date
Received
(30 days to decision)
Product code
EKW Broach, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Walter Lorenz Surgical, Inc. 1520 Tradeport Dr., Jacksonville FL
Third party review
No

Clearances, product code EKW

Trailing 12 months

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

FDA records show no clearances under product code EKW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKW, 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 20260
October 20260