Calix Lumbar Spinal Implant System
K-Number: K170119 · 2017-09-29
ApplicantX-Spine Systems, Inc.
Decision Date2017-09-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Calix Lumbar Spinal Implant System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-09-29 under approval number K170119. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Calix Lumbar Spinal Implant System?
Calix Lumbar Spinal Implant System is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K170119.
When was Calix Lumbar Spinal Implant System approved by the FDA?
Calix Lumbar Spinal Implant System received FDA 510(k) clearance on 2017-09-29, under approval number K170119.
What company makes Calix Lumbar Spinal Implant System?
Calix Lumbar Spinal Implant System is manufactured by X-Spine Systems, Inc..
What is the FDA product code for Calix Lumbar Spinal Implant System?
The FDA product code for Calix Lumbar Spinal Implant System is MAX.
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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.