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FDA 510(k)

ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM

K-Number: K023299 · 2002-12-11

ApplicantAlphatec Mfg., Inc.
Decision Date2002-12-11
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Mfg., Inc.. It received FDA 510(k) clearance on 2002-12-11 under 510(k) number K023299. 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 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM?

ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-11. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K023299.

When did ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM receive FDA 510(k) clearance?

ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM received FDA 510(k) clearance on 2002-12-11, under 510(k) number K023299.

Who is the listed applicant for ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM?

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

What is the FDA product code for ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM?

The FDA product code for ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM is MNI.

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Other records listing Alphatec Mfg., 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.

K033090ICON POLYAXIAL PEDICLE SCREW SYSTEMK020356ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMK993513DELTALOC ANTERIOR CERVICAL PLATE SYSTEMK993873ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION RODK992350PYLON INTRAMEDULLAARY NAIL SYSTEMK980788ALPHATEC WIRE EXTERNAL FIXATION SYSTEM

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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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