NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS

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 Navigated Cd Horizon Solera Screwdriver/taps.

Pre-market Notification Details

Device IDK140454
510k NumberK140454
Device Name:NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
ClassificationOrthopedic Stereotaxic Instrument
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRegina Holmes
CorrespondentRegina Holmes
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 Received2014-02-24
Decision Date2014-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169723795 K140454 000
00643169347526 K140454 000
00643169347533 K140454 000
00643169347540 K140454 000
00643169347557 K140454 000
00643169347564 K140454 000
00643169347595 K140454 000
00643169347601 K140454 000
00643169347618 K140454 000
00643169347625 K140454 000
00643169383180 K140454 000
00643169540903 K140454 000
00643169540910 K140454 000
00643169347519 K140454 000
00643169347502 K140454 000
00643169347380 K140454 000
00643169347397 K140454 000
00643169347403 K140454 000
00643169347410 K140454 000
00643169347427 K140454 000
00643169347434 K140454 000
00643169347441 K140454 000
00643169347458 K140454 000
00643169347465 K140454 000
00643169347472 K140454 000
00643169347489 K140454 000
00643169347496 K140454 000
00643169540927 K140454 000
00643169540934 K140454 000
00643169545809 K140454 000
00643169545816 K140454 000
00643169545823 K140454 000
00643169545830 K140454 000
00643169545847 K140454 000
00643169545854 K140454 000
00643169545861 K140454 000
00643169545878 K140454 000
00643169545885 K140454 000
00643169545892 K140454 000
00643169546875 K140454 000
00643169693821 K140454 000
00643169545793 K140454 000
00643169545786 K140454 000
00643169540941 K140454 000
00643169540958 K140454 000
00643169540965 K140454 000
00643169540972 K140454 000
00643169540989 K140454 000
00643169540996 K140454 000
00643169541009 K140454 000
00643169541016 K140454 000
00643169541023 K140454 000
00643169541030 K140454 000
00643169541047 K140454 000
00643169541054 K140454 000
00643169693838 K140454 000

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