NeoFuse HA Enhanced PLIF/TLIF
K-Number: K153615 · 2016-05-06
ApplicantHt Medical, LLC
Decision Date2016-05-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NeoFuse HA Enhanced PLIF/TLIF is a medical device manufactured by Ht Medical, LLC. It received FDA 510(k) clearance on 2016-05-06 under approval number K153615. 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 NeoFuse HA Enhanced PLIF/TLIF?
NeoFuse HA Enhanced PLIF/TLIF is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Ht Medical, LLC. The 510(k) number is K153615.
When was NeoFuse HA Enhanced PLIF/TLIF approved by the FDA?
NeoFuse HA Enhanced PLIF/TLIF received FDA 510(k) clearance on 2016-05-06, under approval number K153615.
What company makes NeoFuse HA Enhanced PLIF/TLIF?
NeoFuse HA Enhanced PLIF/TLIF is manufactured by Ht Medical, LLC.
What is the FDA product code for NeoFuse HA Enhanced PLIF/TLIF?
The FDA product code for NeoFuse HA Enhanced PLIF/TLIF 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.