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FDA 510(k)

SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K112861 · 2012-02-24

ApplicantSintea Plustek, LLC
Decision Date2012-02-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sintea Plustek, LLC. It received FDA 510(k) clearance on 2012-02-24 under 510(k) number K112861. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM?

SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-24. The listed applicant is Sintea Plustek, LLC. The 510(k) number is K112861.

When did SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2012-02-24, under 510(k) number K112861.

Who is the listed applicant for SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM?

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

What is the FDA product code for SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Sintea Plustek, LLC 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.

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Related Devices (Code: KWQ)

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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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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