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FDA 510(k)

GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS

K-Number: K031782 · 2005-02-01

ApplicantMedtronic Sofamor Danek
Decision Date2005-02-01
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2005-02-01 under 510(k) number K031782. 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 GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS?

GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K031782.

When did GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS receive FDA 510(k) clearance?

GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS received FDA 510(k) clearance on 2005-02-01, under 510(k) number K031782.

Who is the listed applicant for GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS?

The FDA 510(k) record lists Medtronic Sofamor Danek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS?

The FDA product code for GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS 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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