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FDA 510(k)

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System

K-Number: K201614 · 2020-07-15

ApplicantInnovasis, Inc.
Decision Date2020-07-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2020-07-15 under 510(k) number K201614. 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 TxTiHA IBF System, AxTiHA Stand-Alone ALIF System?

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Innovasis, Inc.. The 510(k) number is K201614.

When did TxTiHA IBF System, AxTiHA Stand-Alone ALIF System receive FDA 510(k) clearance?

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System received FDA 510(k) clearance on 2020-07-15, under 510(k) number K201614.

Who is the listed applicant for TxTiHA IBF System, AxTiHA Stand-Alone ALIF System?

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

What is the FDA product code for TxTiHA IBF System, AxTiHA Stand-Alone ALIF System?

The FDA product code for TxTiHA IBF System, AxTiHA Stand-Alone ALIF System is MAX.

Other records listing Innovasis, Inc. 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.

K250076Endeavor™ Stand-Alone Cervical IBF SystemK251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250603AxTiHA® Stand-Alone ALIF SystemK250182Innovasis Navigation InstrumentsK241276Vector™ Pedicle Screw SystemK231899HAtetracell™-C Titanium Cervical IBF System

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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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