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FDA 510(k)

Capstone Control™ Spinal System

K-Number: K190165 · 2019-05-06

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2019-05-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Capstone Control™ Spinal 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 2019-05-06 under 510(k) number K190165. 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 Control™ Spinal System?

Capstone Control™ Spinal System is a medical device that received FDA 510(k) clearance on 2019-05-06. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K190165.

When did Capstone Control™ Spinal System receive FDA 510(k) clearance?

Capstone Control™ Spinal System received FDA 510(k) clearance on 2019-05-06, under 510(k) number K190165.

Who is the listed applicant for Capstone Control™ Spinal 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 Control™ Spinal System?

The FDA product code for Capstone Control™ Spinal System is MAX.

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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