ATEC ALIF and LLIF Spacer System
K-Number: K182746 · 2018-11-27
ApplicantAlphatec Spine, Inc.
Decision Date2018-11-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ATEC ALIF and LLIF Spacer System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2018-11-27 under approval number K182746. 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 ATEC ALIF and LLIF Spacer System?
ATEC ALIF and LLIF Spacer System is a medical device that received FDA 510(k) clearance on 2018-11-27. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K182746.
When was ATEC ALIF and LLIF Spacer System approved by the FDA?
ATEC ALIF and LLIF Spacer System received FDA 510(k) clearance on 2018-11-27, under approval number K182746.
What company makes ATEC ALIF and LLIF Spacer System?
ATEC ALIF and LLIF Spacer System is manufactured by Alphatec Spine, Inc..
What is the FDA product code for ATEC ALIF and LLIF Spacer System?
The FDA product code for ATEC ALIF and LLIF Spacer 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.