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FDA 510(k)

SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K990005 · 1999-02-12

ApplicantSpinal Concepts, Inc.
Decision Date1999-02-12
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE 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 1999-02-12 under 510(k) number K990005. 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 SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM?

SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K990005.

When did SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 1999-02-12, under 510(k) number K990005.

Who is the listed applicant for SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE 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 SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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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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Related Devices (Code: KWQ)

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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