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FDA 510(k)

BUTTERFLY PLATE FUNCTION SYSTEM

K-Number: K010632 · 2001-05-31

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2001-05-31
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BUTTERFLY PLATE FUNCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2001-05-31 under 510(k) number K010632. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUTTERFLY PLATE FUNCTION SYSTEM?

BUTTERFLY PLATE FUNCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-31. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K010632.

When did BUTTERFLY PLATE FUNCTION SYSTEM receive FDA 510(k) clearance?

BUTTERFLY PLATE FUNCTION SYSTEM received FDA 510(k) clearance on 2001-05-31, under 510(k) number K010632.

Who is the listed applicant for BUTTERFLY PLATE FUNCTION SYSTEM?

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

What is the FDA product code for BUTTERFLY PLATE FUNCTION SYSTEM?

The FDA product code for BUTTERFLY PLATE FUNCTION SYSTEM is KWP.

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Related Devices (Code: KWP)

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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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