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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical, LLC. It received FDA 510(k) clearance on 2016-05-06 under 510(k) 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. The listed applicant is Ht Medical, LLC. The 510(k) number is K153615.

When did NeoFuse HA Enhanced PLIF/TLIF receive FDA 510(k) clearance?

NeoFuse HA Enhanced PLIF/TLIF received FDA 510(k) clearance on 2016-05-06, under 510(k) number K153615.

Who is the listed applicant for NeoFuse HA Enhanced PLIF/TLIF?

The FDA 510(k) record lists Ht Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeoFuse HA Enhanced PLIF/TLIF?

The FDA product code for NeoFuse HA Enhanced PLIF/TLIF is MAX.

Other records listing Ht Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyK170511NeoFuse HA Enhanced PLIF/TLIF

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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.

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