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FDA 510(k)

TENSION BAND ANTERIOR SPINAL SYSTEM

K-Number: K071151 · 2007-11-07

ApplicantSpinal Instrumentation Simplification Systems, LLC
Decision Date2007-11-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENSION BAND ANTERIOR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Instrumentation Simplification Systems, LLC. It received FDA 510(k) clearance on 2007-11-07 under 510(k) number K071151. 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 TENSION BAND ANTERIOR SPINAL SYSTEM?

TENSION BAND ANTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-07. The listed applicant is Spinal Instrumentation Simplification Systems, LLC. The 510(k) number is K071151.

When did TENSION BAND ANTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

TENSION BAND ANTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 2007-11-07, under 510(k) number K071151.

Who is the listed applicant for TENSION BAND ANTERIOR SPINAL SYSTEM?

The FDA 510(k) record lists Spinal Instrumentation Simplification Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENSION BAND ANTERIOR SPINAL SYSTEM?

The FDA product code for TENSION BAND ANTERIOR SPINAL SYSTEM is KWQ.

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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.

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