Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Steerable Plateau Ti

K-Number: K193521 · 2020-02-06

ApplicantLife Spine, Inc.
Decision Date2020-02-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Steerable Plateau Ti is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K193521. 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 Steerable Plateau Ti?

Steerable Plateau Ti is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Life Spine, Inc.. The 510(k) number is K193521.

When did Steerable Plateau Ti receive FDA 510(k) clearance?

Steerable Plateau Ti received FDA 510(k) clearance on 2020-02-06, under 510(k) number K193521.

Who is the listed applicant for Steerable Plateau Ti?

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

What is the FDA product code for Steerable Plateau Ti?

The FDA product code for Steerable Plateau Ti is MAX.

Other records listing Life Spine, 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.

K261430TruLift Expandable SystemK260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsK260837VersaLift Expandable SystemK254274ARx® SAI Implant SystemK253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemK251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

View all 68 devices →

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.

↑