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FDA 510(k)

BASIS SPINAL SYSTEM

K-Number: K050484 · 2005-05-04

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2005-05-04
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BASIS SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K050484. 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 BASIS SPINAL SYSTEM?

BASIS SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K050484.

When did BASIS SPINAL SYSTEM receive FDA 510(k) clearance?

BASIS SPINAL SYSTEM received FDA 510(k) clearance on 2005-05-04, under 510(k) number K050484.

Who is the listed applicant for BASIS SPINAL SYSTEM?

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

What is the FDA product code for BASIS SPINAL SYSTEM?

The FDA product code for BASIS SPINAL 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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