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FDA 510(k)

PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS

K-Number: K092474 · 2010-03-11

ApplicantK2m, Inc.
Decision Date2010-03-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K092474. 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, SEMI-CONSTRAINED SCREWS?

PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is K2m, Inc.. The 510(k) number is K092474.

When did PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS receive FDA 510(k) clearance?

PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS received FDA 510(k) clearance on 2010-03-11, under 510(k) number K092474.

Who is the listed applicant for PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS?

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, SEMI-CONSTRAINED SCREWS?

The FDA product code for PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS 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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