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)

Zyston Strut Open Titanium Spacer System

K-Number: K171495 · 2018-02-12

ApplicantZimmer Biomet Spine, Inc.
Decision Date2018-02-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zyston Strut Open Titanium Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K171495. 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 Zyston Strut Open Titanium Spacer System?

Zyston Strut Open Titanium Spacer System is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Zimmer Biomet Spine, Inc.. The 510(k) number is K171495.

When did Zyston Strut Open Titanium Spacer System receive FDA 510(k) clearance?

Zyston Strut Open Titanium Spacer System received FDA 510(k) clearance on 2018-02-12, under 510(k) number K171495.

Who is the listed applicant for Zyston Strut Open Titanium Spacer System?

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

What is the FDA product code for Zyston Strut Open Titanium Spacer System?

The FDA product code for Zyston Strut Open Titanium Spacer System is MAX.

Other records listing Zimmer Biomet 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.

K212023Virage Navigation SystemK203218CaP Spheres Pellet PackK210275Polaris Spinal SystemK203507Vitality® Spinal Fixation SystemK202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion SystemK191722Vital Navigation System

View all 15 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.

↑