Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System Incorporating Various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; And System Accessories

Motor, Drill, Pneumatic

Medtronic Powered Surgical Solutions

The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Medtronic Legend Pneumatic; Mr7 Pneumatic; Triton Pneumatic Drill System Incorporating Various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; And System Accessories.

Pre-market Notification Details

Device IDK163182
510k NumberK163182
Device Name:Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System Incorporating Various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; And System Accessories
ClassificationMotor, Drill, Pneumatic
Applicant Medtronic Powered Surgical Solutions 4620 North Beach Street Fox Worth,  TX  76177
ContactDeep Pal
CorrespondentDeep Pal
Medtronic Powered Surgical Solutions 4620 North Beach Street Fox Worth,  TX  76177
Product CodeHBB  
Subsequent Product CodeDWH
Subsequent Product CodeEQJ
Subsequent Product CodeERL
Subsequent Product CodeGET
Subsequent Product CodeHBE
Subsequent Product CodeHSZ
Subsequent Product CodeKFK
CFR Regulation Number882.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-14
Decision Date2017-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000096762 K163182 000
00763000430962 K163182 000
00763000430979 K163182 000
00763000337551 K163182 000
00763000337568 K163182 000
00763000337506 K163182 000
00763000080143 K163182 000
00763000080044 K163182 000
00763000080068 K163182 000
00763000080075 K163182 000
00763000096717 K163182 000
00763000096724 K163182 000
00763000096748 K163182 000
00763000096755 K163182 000
00763000430955 K163182 000

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