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FDA 510(k)

VERTEBRON PSS PEDICLE SCREW SYSTEM

K-Number: K043152 · 2005-02-01

ApplicantVertebron, Inc.
Decision Date2005-02-01
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTEBRON PSS PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vertebron, Inc.. It received FDA 510(k) clearance on 2005-02-01 under 510(k) number K043152. 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 VERTEBRON PSS PEDICLE SCREW SYSTEM?

VERTEBRON PSS PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Vertebron, Inc.. The 510(k) number is K043152.

When did VERTEBRON PSS PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

VERTEBRON PSS PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2005-02-01, under 510(k) number K043152.

Who is the listed applicant for VERTEBRON PSS PEDICLE SCREW SYSTEM?

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

What is the FDA product code for VERTEBRON PSS PEDICLE SCREW SYSTEM?

The FDA product code for VERTEBRON PSS PEDICLE SCREW SYSTEM is MNH. This falls under the ENT category.

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Other records listing Vertebron, 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.

K081567VERTEBRON SSP CERVICAL PLATING SYSTEMK081597MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEMK073502VERTEBRON VBR SYSTEMK071376MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEMK062110VERTEBRON SCP CERVICAL PLATE SYSTEMK051815MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM

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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

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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