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FDA 510(k)

NOVEL SPINAL SPACER SYSTEM

K-Number: K080699 · 2008-05-21

ApplicantAlphatec Spine, Inc.
Decision Date2008-05-21
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVEL SPINAL SPACER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2008-05-21 under 510(k) number K080699. 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 NOVEL SPINAL SPACER SYSTEM?

NOVEL SPINAL SPACER SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-21. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K080699.

When did NOVEL SPINAL SPACER SYSTEM receive FDA 510(k) clearance?

NOVEL SPINAL SPACER SYSTEM received FDA 510(k) clearance on 2008-05-21, under 510(k) number K080699.

Who is the listed applicant for NOVEL SPINAL SPACER SYSTEM?

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

What is the FDA product code for NOVEL SPINAL SPACER SYSTEM?

The FDA product code for NOVEL SPINAL SPACER SYSTEM is MQP.

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Other records listing Alphatec Spine, Inc. as applicant

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Related Devices (Code: MQP)

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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