Capstone Control™ Spinal System

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Capstone Control™ Spinal System.

Pre-market Notification Details

Device IDK190165
510k NumberK190165
Device Name:Capstone Control™ Spinal System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis,  TN  38132
ContactJustin O'connor
CorrespondentJustin O'connor
Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-31
Decision Date2019-05-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000121303 K190165 000
00763000121310 K190165 000
00763000121327 K190165 000
00763000121334 K190165 000
00763000121341 K190165 000
00763000121358 K190165 000
00763000121365 K190165 000
00763000121372 K190165 000
00763000121389 K190165 000
00763000121396 K190165 000
00763000121402 K190165 000
00763000121419 K190165 000
00763000121426 K190165 000
00763000121433 K190165 000
00763000121440 K190165 000
00763000121457 K190165 000
00763000121464 K190165 000
00763000121297 K190165 000

Trademark Results [Capstone Control]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSTONE CONTROL
CAPSTONE CONTROL
85253149 4324898 Live/Registered
Medtronic, Inc.
2011-02-28

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