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FDA 510(k)

PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)

K-Number: K111135 · 2011-08-17

ApplicantK2m, Inc.
Decision Date2011-08-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2011-08-17 under 510(k) number K111135. 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 PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)?

PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) is a medical device that received FDA 510(k) clearance on 2011-08-17. The listed applicant is K2m, Inc.. The 510(k) number is K111135.

When did PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) receive FDA 510(k) clearance?

PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) received FDA 510(k) clearance on 2011-08-17, under 510(k) number K111135.

Who is the listed applicant for PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)?

The FDA product code for PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) is KWQ.

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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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