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)

Arlington PLIF/TLIF Cage

K-Number: K172020 · 2017-11-29

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2017-11-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arlington PLIF/TLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172020. 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 Arlington PLIF/TLIF Cage?

Arlington PLIF/TLIF Cage is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K172020.

When did Arlington PLIF/TLIF Cage receive FDA 510(k) clearance?

Arlington PLIF/TLIF Cage received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172020.

Who is the listed applicant for Arlington PLIF/TLIF Cage?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arlington PLIF/TLIF Cage?

The FDA product code for Arlington PLIF/TLIF Cage is MAX.

Other records listing Signature Orthopaedics Pty, Ltd. 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.

K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadK253239Active-V Total Knee System; World Total Knee SystemK251771Cambridge Partial KneeK243021Longboard Revision Hip StemK242674Freedom Posterior Cervical ScrewsK242477Shoulder Soft Tissue Anchors

View all 42 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.

↑