CD HORIZON Spinal System Instruments For Use With MAZOR X Stealth Edition

Orthopedic Stereotaxic Instrument

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 Cd Horizon Spinal System Instruments For Use With Mazor X Stealth Edition.

Pre-market Notification Details

Device IDK182121
510k NumberK182121
Device Name:CD HORIZON Spinal System Instruments For Use With MAZOR X Stealth Edition
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactErikka Edwardsen
CorrespondentErikka Edwardsen
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-06
Decision Date2018-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000516192 K182121 000
00763000023645 K182121 000
00763000023638 K182121 000
00763000023621 K182121 000
00763000011369 K182121 000
00763000011352 K182121 000
00763000011345 K182121 000
00763000011338 K182121 000
00763000011321 K182121 000
00763000023652 K182121 000
00763000023669 K182121 000
00763000023744 K182121 000
00763000023737 K182121 000
00763000023720 K182121 000
00763000023713 K182121 000
00763000023706 K182121 000
00763000023690 K182121 000
00763000023683 K182121 000
00763000023676 K182121 000
00763000011314 K182121 000
00763000011307 K182121 000
00763000306809 K182121 000
00763000374105 K182121 000
00763000374099 K182121 000
00763000374082 K182121 000
00763000374075 K182121 000
00763000516222 K182121 000
00763000516215 K182121 000
00763000516208 K182121 000
00763000306816 K182121 000
00763000306823 K182121 000
00763000011291 K182121 000
00763000011284 K182121 000
00763000011277 K182121 000
00763000011260 K182121 000
00763000011253 K182121 000
00763000011246 K182121 000
00763000011239 K182121 000
00763000011222 K182121 000
00763000023751 K182121 000
00763000023768 K182121 000
00763000140359 K182121 000
00763000140311 K182121 000
00763000092511 K182121 000
00763000092504 K182121 000
00763000082420 K182121 000
00763000082413 K182121 000
00763000082406 K182121 000
00763000082390 K182121 000
00763000140366 K182121 000
00763000140373 K182121 000
00763000141479 K182121 000
00763000141462 K182121 000
00763000140489 K182121 000
00763000140465 K182121 000
00763000140434 K182121 000
00763000140427 K182121 000
00763000140410 K182121 000
00763000140380 K182121 000
00763000082383 K182121 000
00763000082376 K182121 000
00763000082185 K182121 000
00763000082178 K182121 000
00763000082154 K182121 000
00763000082109 K182121 000
00763000082093 K182121 000
00763000082086 K182121 000
00763000023782 K182121 000
00763000023775 K182121 000
00763000082192 K182121 000
00763000082239 K182121 000
00763000082314 K182121 000
00763000082307 K182121 000
00763000082291 K182121 000
00763000082284 K182121 000
00763000082277 K182121 000
00763000082260 K182121 000
00763000082253 K182121 000
00763000082246 K182121 000
00763000159603 K182121 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.