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FDA 510(k)

MX POLYAXIAL PEDICLE SCREW

K-Number: K043001 · 2004-12-01

ApplicantScient'X
Decision Date2004-12-01
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MX POLYAXIAL PEDICLE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K043001. 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 MX POLYAXIAL PEDICLE SCREW?

MX POLYAXIAL PEDICLE SCREW is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Scient'X. The 510(k) number is K043001.

When did MX POLYAXIAL PEDICLE SCREW receive FDA 510(k) clearance?

MX POLYAXIAL PEDICLE SCREW received FDA 510(k) clearance on 2004-12-01, under 510(k) number K043001.

Who is the listed applicant for MX POLYAXIAL PEDICLE SCREW?

The FDA 510(k) record lists Scient'X as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MX POLYAXIAL PEDICLE SCREW?

The FDA product code for MX POLYAXIAL PEDICLE SCREW is MNH. This falls under the ENT category.

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Other records listing Scient'X 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.

K071261ISOBAR SEMI-RIGID DUAL DAMPENERK062912SCIENT'X SPINAL SYSTEMK052763STELLA CERVICAL PLATEK052367SCIENT'X CEMENT RESTRICTORK050348CO VERTEBRAL BODY REPLACEMENTK051063POLYAXIAL HEMISPHERICAL SPINAL SCREWS

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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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