FDA 510(k)

ABBOTT SPINE, INC. SPINNAKER SYSTEM

K-Number: K052638 · 2005-11-07

Decision Date2005-11-07

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ABBOTT SPINE, INC. SPINNAKER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Spine, Inc.. It received FDA 510(k) clearance on 2005-11-07 under 510(k) number K052638. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT SPINE, INC. SPINNAKER SYSTEM?

ABBOTT SPINE, INC. SPINNAKER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-07. The listed applicant is Abbott Spine, Inc.. The 510(k) number is K052638.

When did ABBOTT SPINE, INC. SPINNAKER SYSTEM receive FDA 510(k) clearance?

ABBOTT SPINE, INC. SPINNAKER SYSTEM received FDA 510(k) clearance on 2005-11-07, under 510(k) number K052638.

Who is the listed applicant for ABBOTT SPINE, INC. SPINNAKER SYSTEM?

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

What is the FDA product code for ABBOTT SPINE, INC. SPINNAKER SYSTEM?

The FDA product code for ABBOTT SPINE, INC. SPINNAKER SYSTEM is KNW.

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Other records listing Abbott Spine, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.