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FDA 510(k)

SPINAL CONCEPTS INC. CODA

K-Number: K033663 · 2004-05-27

ApplicantSpinal Concepts, Inc.
Decision Date2004-05-27
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL CONCEPTS INC. CODA 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 2004-05-27 under 510(k) number K033663. 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. CODA?

SPINAL CONCEPTS INC. CODA is a medical device that received FDA 510(k) clearance on 2004-05-27. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K033663.

When did SPINAL CONCEPTS INC. CODA receive FDA 510(k) clearance?

SPINAL CONCEPTS INC. CODA received FDA 510(k) clearance on 2004-05-27, under 510(k) number K033663.

Who is the listed applicant for SPINAL CONCEPTS INC. CODA?

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. CODA?

The FDA product code for SPINAL CONCEPTS INC. CODA is MQP.

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Other records listing Spinal Concepts, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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