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)

PARALLAX EZFLOW CEMENT DELIVERY SYSTEM

K-Number: K051820 · 2005-09-06

ApplicantArthrocare Corp.
Decision Date2005-09-06
Product CodeOAR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARALLAX EZFLOW CEMENT DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2005-09-06 under 510(k) number K051820. The device is classified under product code OAR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARALLAX EZFLOW CEMENT DELIVERY SYSTEM?

PARALLAX EZFLOW CEMENT DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-06. The listed applicant is Arthrocare Corp.. The 510(k) number is K051820.

When did PARALLAX EZFLOW CEMENT DELIVERY SYSTEM receive FDA 510(k) clearance?

PARALLAX EZFLOW CEMENT DELIVERY SYSTEM received FDA 510(k) clearance on 2005-09-06, under 510(k) number K051820.

Who is the listed applicant for PARALLAX EZFLOW CEMENT DELIVERY SYSTEM?

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

What is the FDA product code for PARALLAX EZFLOW CEMENT DELIVERY SYSTEM?

The FDA product code for PARALLAX EZFLOW CEMENT DELIVERY SYSTEM is OAR.

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 Arthrocare Corp. 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.

K153186Adjustable Fixation DeviceK131709SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENTK130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DRK111399SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75K111397TITAN TI SUTURE ANCHOR SYSTEMK1107815.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP

View all 112 devices →

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.

↑