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FDA 510(k)

PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES

K-Number: K111528 · 2011-08-24

Decision Date2011-08-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2011-08-24 under 510(k) number K111528. 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 PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES?

PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES is a medical device that received FDA 510(k) clearance on 2011-08-24. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K111528.

When did PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES receive FDA 510(k) clearance?

PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES received FDA 510(k) clearance on 2011-08-24, under 510(k) number K111528.

Who is the listed applicant for PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES?

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

What is the FDA product code for PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES?

The FDA product code for PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES is KWQ.

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.

Other records listing Pioneer Surgical Technology, 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.

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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.

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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