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)

ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION

K-Number: K922766 · 1993-07-09

ApplicantAcufex Microsurgical, Inc.
Decision Date1993-07-09
Product CodeHTY
Advisory CommitteeOR
DecisionUnknown

Device Summary

ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K922766. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION?

ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K922766.

When did ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION receive FDA 510(k) clearance?

ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION received FDA 510(k) clearance on 1993-07-09, under 510(k) number K922766.

Who is the listed applicant for ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION?

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

What is the FDA product code for ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION?

The FDA product code for ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION 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 Acufex Microsurgical, 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

View all 78 devices →

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.

↑