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FDA 510(k)

STAXXSD SYSTEM

K-Number: K111469 · 2011-07-19

ApplicantSpine Wave, Inc.
Decision Date2011-07-19
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAXXSD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2011-07-19 under 510(k) number K111469. 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 STAXXSD SYSTEM?

STAXXSD SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-19. The listed applicant is Spine Wave, Inc.. The 510(k) number is K111469.

When did STAXXSD SYSTEM receive FDA 510(k) clearance?

STAXXSD SYSTEM received FDA 510(k) clearance on 2011-07-19, under 510(k) number K111469.

Who is the listed applicant for STAXXSD SYSTEM?

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

What is the FDA product code for STAXXSD SYSTEM?

The FDA product code for STAXXSD SYSTEM is MQP.

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Other records listing Spine Wave, 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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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