ATEC Universal Spacer System
K-Number: K180480 · 2018-05-31
ApplicantAlphatec Spine, Inc.
Decision Date2018-05-31
Product CodePHM
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ATEC Universal Spacer System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2018-05-31 under approval number K180480. The device is classified under product code PHM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ATEC Universal Spacer System?
ATEC Universal Spacer System is a medical device that received FDA 510(k) clearance on 2018-05-31. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K180480.
When was ATEC Universal Spacer System approved by the FDA?
ATEC Universal Spacer System received FDA 510(k) clearance on 2018-05-31, under approval number K180480.
What company makes ATEC Universal Spacer System?
ATEC Universal Spacer System is manufactured by Alphatec Spine, Inc..
What is the FDA product code for ATEC Universal Spacer System?
The FDA product code for ATEC Universal Spacer System is PHM.
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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.