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FDA 510(k)

SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM

K-Number: K051697 · 2005-09-21

Decision Date2005-09-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Advisory Development Group. It received FDA 510(k) clearance on 2005-09-21 under 510(k) number K051697. 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 SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM?

SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Medical Device Advisory Development Group. The 510(k) number is K051697.

When did SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM receive FDA 510(k) clearance?

SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM received FDA 510(k) clearance on 2005-09-21, under 510(k) number K051697.

Who is the listed applicant for SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM?

The FDA 510(k) record lists Medical Device Advisory Development Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM?

The FDA product code for SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING 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.

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.

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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