Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE

K-Number: K925098 · 1994-07-19

ApplicantBioscience, Inc.
Decision Date1994-07-19
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE is the device name listed in this FDA 510(k) record. The listed applicant is Bioscience, Inc.. It received FDA 510(k) clearance on 1994-07-19 under 510(k) number K925098. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE?

BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE is a medical device that received FDA 510(k) clearance on 1994-07-19. The listed applicant is Bioscience, Inc.. The 510(k) number is K925098.

When did BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE receive FDA 510(k) clearance?

BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE received FDA 510(k) clearance on 1994-07-19, under 510(k) number K925098.

Who is the listed applicant for BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE?

The FDA 510(k) record lists Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE?

The FDA product code for BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE is HTY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bioscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955768BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEMK955003BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACKK952471BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD

Related Devices (Code: HTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑