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)

UNiD Patient specific 3D printed TLIF cage

K-Number: K190092 · 2019-05-08

ApplicantMedicrea International SA
Decision Date2019-05-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNiD Patient specific 3D printed TLIF cage is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2019-05-08 under 510(k) number K190092. 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 UNiD Patient specific 3D printed TLIF cage?

UNiD Patient specific 3D printed TLIF cage is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is Medicrea International SA. The 510(k) number is K190092.

When did UNiD Patient specific 3D printed TLIF cage receive FDA 510(k) clearance?

UNiD Patient specific 3D printed TLIF cage received FDA 510(k) clearance on 2019-05-08, under 510(k) number K190092.

Who is the listed applicant for UNiD Patient specific 3D printed TLIF cage?

The FDA 510(k) record lists Medicrea International SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNiD Patient specific 3D printed TLIF cage?

The FDA product code for UNiD Patient specific 3D printed TLIF cage is MAX.

Other records listing Medicrea International SA 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.

K213659LigaPASS™ 2.0 Ligament Augmentation SystemK220810Infinity™ OCT System and PASS OCT Spinal SystemK220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemK212005UNiD Spine AnalyzerK213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemK210470C-CURVE Interbody Fusion Device

View all 27 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.

↑