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FDA 510(k)

MEDTRONIC(R) ORTHOFLEX(TM)

K-Number: K874884 · 1988-01-28

ApplicantMetronic, Inc.
Decision Date1988-01-28
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC(R) ORTHOFLEX(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Metronic, Inc.. It received FDA 510(k) clearance on 1988-01-28 under 510(k) number K874884. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC(R) ORTHOFLEX(TM)?

MEDTRONIC(R) ORTHOFLEX(TM) is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Metronic, Inc.. The 510(k) number is K874884.

When did MEDTRONIC(R) ORTHOFLEX(TM) receive FDA 510(k) clearance?

MEDTRONIC(R) ORTHOFLEX(TM) received FDA 510(k) clearance on 1988-01-28, under 510(k) number K874884.

Who is the listed applicant for MEDTRONIC(R) ORTHOFLEX(TM)?

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

What is the FDA product code for MEDTRONIC(R) ORTHOFLEX(TM)?

The FDA product code for MEDTRONIC(R) ORTHOFLEX(TM) is BXB.

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 Metronic, 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.

K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADK911827MODEL 5866-9M & MODEL 6981MK832505IMAGE PROCESSING SYS A3

Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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