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FDA 510(k)

TRACERS BONE CEMENT OPACIFIER

K-Number: K023445 · 2003-03-11

ApplicantParallax Medical, Inc.
Decision Date2003-03-11
Product CodeMYU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRACERS BONE CEMENT OPACIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Parallax Medical, Inc.. It received FDA 510(k) clearance on 2003-03-11 under 510(k) number K023445. The device is classified under product code MYU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACERS BONE CEMENT OPACIFIER?

TRACERS BONE CEMENT OPACIFIER is a medical device that received FDA 510(k) clearance on 2003-03-11. The listed applicant is Parallax Medical, Inc.. The 510(k) number is K023445.

When did TRACERS BONE CEMENT OPACIFIER receive FDA 510(k) clearance?

TRACERS BONE CEMENT OPACIFIER received FDA 510(k) clearance on 2003-03-11, under 510(k) number K023445.

Who is the listed applicant for TRACERS BONE CEMENT OPACIFIER?

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

What is the FDA product code for TRACERS BONE CEMENT OPACIFIER?

The FDA product code for TRACERS BONE CEMENT OPACIFIER is MYU.

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 Parallax Medical, 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.

K033230TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAK022169CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLESK011206PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLESK994022PARALLAX CRANIOSETK991893PARALLAX TRACER RADIOPAQUE PARTICLES

Related Devices (Code: MYU)

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.

K033230TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAParallax Medical, Inc.K032388BONE CEMENT RADIO-OPACIFIERCardinalhealthK024359VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1Vista Scientific, LLCK002063BIOTRACE, MODEL 1730Bryan Corp.K991893PARALLAX TRACER RADIOPAQUE PARTICLESParallax Medical, 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.

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