510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896667Substantially Equivalent

Lorenz Stent

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

K896667 is the FDA 510(k) clearance record for LORENZ STENT, a class II device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code FWN (Prosthesis, Larynx (Stents And Keels)). FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K896667.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FWN Prosthesis, Larynx (Stents And Keels)
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Walter Lorenz Surgical, Inc. 1520 Tradeport Dr., Jacksonville FL
Third party review
No

Clearances, product code FWN

Trailing 12 months

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

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