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)

FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM

K-Number: K032427 · 2003-10-09

ApplicantMeridan Medical
Decision Date2003-10-09
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Meridan Medical. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K032427. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM?

FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Meridan Medical. The 510(k) number is K032427.

When did FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM receive FDA 510(k) clearance?

FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032427.

Who is the listed applicant for FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM?

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

What is the FDA product code for FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM?

The FDA product code for FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM is JEC.

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 Meridan Medical 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.

K070016BLUE SHARK

Related Devices (Code: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.

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.

↑