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FDA 510(k)

UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM

K-Number: K014302 · 2002-03-29

ApplicantPisharodi Surgicals, Inc.
Decision Date2002-03-29
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pisharodi Surgicals, Inc.. It received FDA 510(k) clearance on 2002-03-29 under 510(k) number K014302. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM?

UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-29. The listed applicant is Pisharodi Surgicals, Inc.. The 510(k) number is K014302.

When did UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2002-03-29, under 510(k) number K014302.

Who is the listed applicant for UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM?

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

What is the FDA product code for UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM?

The FDA product code for UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM is MNH. This falls under the ENT category.

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 Pisharodi Surgicals, 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.

K070335SIMPLEX CERVICAL FIXATION SYSTEMK033951RADIX CERVICAL PLATEK024313MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM

Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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