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FDA 510(k)

INCOMPASS SPINAL FIXATION SYSTEM

K-Number: K021564 · 2002-10-25

ApplicantSpinal Concepts, Inc.
Decision Date2002-10-25
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INCOMPASS SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Concepts, Inc.. It received FDA 510(k) clearance on 2002-10-25 under 510(k) number K021564. 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 INCOMPASS SPINAL FIXATION SYSTEM?

INCOMPASS SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-10-25. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K021564.

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

INCOMPASS SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2002-10-25, under 510(k) number K021564.

Who is the listed applicant for INCOMPASS SPINAL FIXATION SYSTEM?

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

What is the FDA product code for INCOMPASS SPINAL FIXATION SYSTEM?

The FDA product code for INCOMPASS SPINAL FIXATION SYSTEM is KWQ.

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Other records listing Spinal Concepts, Inc. as applicant

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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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