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FDA 510(k)

SPINAL CONCEPTS INC. CADENCE AND TRAXIS

K-Number: K033517 · 2004-02-18

ApplicantSpinal Concepts, Inc.
Decision Date2004-02-18
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL CONCEPTS INC. CADENCE AND TRAXIS 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 2004-02-18 under 510(k) number K033517. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL CONCEPTS INC. CADENCE AND TRAXIS?

SPINAL CONCEPTS INC. CADENCE AND TRAXIS is a medical device that received FDA 510(k) clearance on 2004-02-18. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K033517.

When did SPINAL CONCEPTS INC. CADENCE AND TRAXIS receive FDA 510(k) clearance?

SPINAL CONCEPTS INC. CADENCE AND TRAXIS received FDA 510(k) clearance on 2004-02-18, under 510(k) number K033517.

Who is the listed applicant for SPINAL CONCEPTS INC. CADENCE AND TRAXIS?

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 SPINAL CONCEPTS INC. CADENCE AND TRAXIS?

The FDA product code for SPINAL CONCEPTS INC. CADENCE AND TRAXIS is MQP.

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Other records listing Spinal Concepts, 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.

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