510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K053492Substantially Equivalent

Bioduct

Bioduct, LLC, Fort Wayne IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053492 is the FDA 510(k) clearance record for BIODUCT, a class II device, cleared for Bioduct, LLC on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list one 510(k) clearance for Bioduct, LLC. As of , FDA records show no recalls naming K053492.

Clearance record

Decision date
Received
(483 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Bioduct, LLC 3201 Stellhorn Rd., Fort Wayne IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAI

Trailing 12 months
5 clearances under product code MAI in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260