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FDA 510(k)

AMT POLYAXIAL PEDICLE SCREW

K-Number: K022768 · 2002-11-13

ApplicantMicron Precision Engineering, Inc.
Decision Date2002-11-13
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMT POLYAXIAL PEDICLE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Micron Precision Engineering, Inc.. It received FDA 510(k) clearance on 2002-11-13 under 510(k) number K022768. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMT POLYAXIAL PEDICLE SCREW?

AMT POLYAXIAL PEDICLE SCREW is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is Micron Precision Engineering, Inc.. The 510(k) number is K022768.

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

AMT POLYAXIAL PEDICLE SCREW received FDA 510(k) clearance on 2002-11-13, under 510(k) number K022768.

Who is the listed applicant for AMT POLYAXIAL PEDICLE SCREW?

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

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

The FDA product code for AMT POLYAXIAL PEDICLE SCREW is MNI.

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.

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Other records listing Micron Precision Engineering, 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.

K002059AMT SPINAL SYSTEM

Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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