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FDA 510(k)

FlareHawk TiHawk9 Interbody Fusion System

K-Number: K201367 · 2020-09-23

ApplicantIntegrity Implants, Inc.
Decision Date2020-09-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FlareHawk TiHawk9 Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Implants, Inc.. It received FDA 510(k) clearance on 2020-09-23 under 510(k) number K201367. 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 FlareHawk TiHawk9 Interbody Fusion System?

FlareHawk TiHawk9 Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Integrity Implants, Inc.. The 510(k) number is K201367.

When did FlareHawk TiHawk9 Interbody Fusion System receive FDA 510(k) clearance?

FlareHawk TiHawk9 Interbody Fusion System received FDA 510(k) clearance on 2020-09-23, under 510(k) number K201367.

Who is the listed applicant for FlareHawk TiHawk9 Interbody Fusion System?

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

What is the FDA product code for FlareHawk TiHawk9 Interbody Fusion System?

The FDA product code for FlareHawk TiHawk9 Interbody Fusion System is MAX.

Other records listing Integrity Implants, 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.

K231098LineSider® Spinal SystemK213355Toro-L Interbody Fusion SystemK220453FlareHawk Interbody Fusion SystemK212088Integrity Implants Navigated InstrumentsK203038Toro-L Interbody Fusion SystemK203367LineSider™ Spinal 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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