FDA 510(k)

Toro-L Interbody Fusion System

K-Number: K213355 · 2022-03-25

Decision Date2022-03-25

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Toro-L 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 2022-03-25 under 510(k) number K213355. 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 Toro-L Interbody Fusion System?

Toro-L Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Integrity Implants, Inc.. The 510(k) number is K213355.

When did Toro-L Interbody Fusion System receive FDA 510(k) clearance?

Toro-L Interbody Fusion System received FDA 510(k) clearance on 2022-03-25, under 510(k) number K213355.

Who is the listed applicant for Toro-L 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 Toro-L Interbody Fusion System?

The FDA product code for Toro-L 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 System K220453FlareHawk Interbody Fusion System K212088Integrity Implants Navigated Instruments K203038Toro-L Interbody Fusion System K203367LineSider™ Spinal System K202198FlareHawk Interbody Fusion System

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Related Devices (Code: MAX)

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 Corporation K253151Fule 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.