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FDA 510(k)

ORTHOTRAC COAXIAL LASER

K-Number: K933431 · 1993-10-05

ApplicantTrac Medical, Inc.
Decision Date1993-10-05
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOTRAC COAXIAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Trac Medical, Inc.. It received FDA 510(k) clearance on 1993-10-05 under 510(k) number K933431. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOTRAC COAXIAL LASER?

ORTHOTRAC COAXIAL LASER is a medical device that received FDA 510(k) clearance on 1993-10-05. The listed applicant is Trac Medical, Inc.. The 510(k) number is K933431.

When did ORTHOTRAC COAXIAL LASER receive FDA 510(k) clearance?

ORTHOTRAC COAXIAL LASER received FDA 510(k) clearance on 1993-10-05, under 510(k) number K933431.

Who is the listed applicant for ORTHOTRAC COAXIAL LASER?

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

What is the FDA product code for ORTHOTRAC COAXIAL LASER?

The FDA product code for ORTHOTRAC COAXIAL LASER is OXO.

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 Trac 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.

K944345BEDSIDE BUTLER

Related Devices (Code: OXO)

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.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.

Official Source

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

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