BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE— 510(k) K925098

Substantially Equivalent for Some Indications

Bioscience, Inc.

FDA 510(k) clearance K925098 for BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE, Substantially Equivalent for Some Indications on 1994-07-19. Applicant: Bioscience, Inc..

Clearance details

Applicant: Bioscience, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1992-10-08
Decision date: 1994-07-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.