ProLift Lateral HELO Fixated
K-Number: K210061 · 2021-04-30
ApplicantLife Spine, Inc.
Decision Date2021-04-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ProLift Lateral HELO Fixated is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2021-04-30 under approval number K210061. 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 ProLift Lateral HELO Fixated?
ProLift Lateral HELO Fixated is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Life Spine, Inc.. The 510(k) number is K210061.
When was ProLift Lateral HELO Fixated approved by the FDA?
ProLift Lateral HELO Fixated received FDA 510(k) clearance on 2021-04-30, under approval number K210061.
What company makes ProLift Lateral HELO Fixated?
ProLift Lateral HELO Fixated is manufactured by Life Spine, Inc..
What is the FDA product code for ProLift Lateral HELO Fixated?
The FDA product code for ProLift Lateral HELO Fixated is MAX.
Other Devices by Life Spine, Inc.
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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.