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FDA 510(k)

CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

K-Number: K191788 · 2020-03-23

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2020-03-23
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2020-03-23 under 510(k) number K191788. 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 CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System?

CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System is a medical device that received FDA 510(k) clearance on 2020-03-23. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K191788.

When did CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System receive FDA 510(k) clearance?

CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System received FDA 510(k) clearance on 2020-03-23, under 510(k) number K191788.

Who is the listed applicant for CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System?

The FDA product code for CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System is MAX.

Related Clinical Trials

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.

NCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITINGNCT05037968MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral FusionRECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITINGNCT06259409Regenn® Therapy System Safety StudyACTIVE_NOT_RECRUITINGNCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING

Other records listing Medtronic Sofamor Danek USA, Inc. as applicant

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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.

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