Simplify® Cervical Artificial Disc SM-6

GUDID 00843285100047

Simplify® Cervical Artificial Disc Size SM, Height 6

Simplify Medical, Inc.

Cervical total intervertebral disc replacement prosthesis
Primary Device ID00843285100047
NIH Device Record Keye8714fdc-7010-4a00-ac2d-91fa9613fd62
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplify® Cervical Artificial Disc
Version Model NumberA
Catalog NumberSM-6
Company DUNS075663686
Company NameSimplify Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone650-947-3472
Emailinfo@simplifymedical.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Dimensions

Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter
Height6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843285100047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJOProsthesis, Intervertebral Disc

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-22
Device Publish Date2020-12-14

On-Brand Devices [Simplify® Cervical Artificial Disc ]

00843285101754Simplify® Inserter, Size LG
00843285101747Simplify® Inserter, Size MD
00843285101730Simplify® Inserter, Size SM
00843285101693Simplify® Slot Cutter, Size MD, 4mm
00843285101686Simplify® Slot Cutter, Size SM, 4mm
00843285100955Simplify® Depth Gauge, Size LG
00843285100948Simplify® Depth Gauge, Size MD
00843285100931Simplify® Depth Gauge, Size SM
00843285100771Simplify® Trial, Size LG, Height 6, 5° Lordosis
00843285100764Simplify® Trial, Size LG, Height 6
00843285100757Simplify® Trial, Size LG, Height 5, 5° Lordosis
00843285100740Simplify® Trial, Size LG, Height 5
00843285100733Simplify® Trial, Size MD, Height 6, 5° Lordosis
00843285100726Simplify® Trial, Size MD, Height 6
00843285100719Simplify® Trial, Size MD, Height 5, 5° Lordosis
00843285100702Simplify® Trial, Size MD, Height 5
00843285100696Simplify® Trial, Size MD, Height 4
00843285100689Simplify® Trial, Size SM, Height 6
00843285100665Simplify® Trial, Size SM, Height 5
00843285100627Simplify® Trial, Size SM, Height 4
00843285100139Simplify® Cervical Artificial Disc Size LG, Height 6, 5° Lordosis
00843285100122Simplify® Cervical Artificial Disc Size LG, Height 6
00843285100115Simplify® Cervical Artificial Disc Size LG, Height 5, 5° Lordosis
00843285100108Simplify® Cervical Artificial Disc Size LG, Height 5
00843285100092Simplify® Cervical Artificial Disc Size MD, Height 6, 5° Lordosis
00843285100085Simplify® Cervical Artificial Disc Size MD, Height 6
00843285100078Simplify® Cervical Artificial Disc Size MD, Height 5, 5° Lordosis
00843285100061Simplify® Cervical Artificial Disc Size MD, Height 5
00843285100054Simplify® Cervical Artificial Disc Size MD, Height 4
00843285100047Simplify® Cervical Artificial Disc Size SM, Height 6
00843285100030Simplify® Cervical Artificial Disc Size SM, Height 5, 5° Lordosis
00843285100023Simplify® Cervical Artificial Disc Size SM, Height 5
00843285100016Simplify® Cervical Artificial Disc Size SM, Height 4, 5° Lordosis
00843285100009Simplify® Cervical Artificial Disc Size SM, Height 4
00843285101709Simplify® Slot Cutter, Size SM, 5/6mm

Trademark Results [Simplify]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLIFY
SIMPLIFY
98596744 not registered Live/Pending
Simplify Workforce, Inc
2024-06-12
SIMPLIFY
SIMPLIFY
98239372 not registered Live/Pending
SIMPLIFYAI LLC
2023-10-25
SIMPLIFY
SIMPLIFY
98102133 not registered Live/Pending
SIMPLIFYAI LLC
2023-07-26
SIMPLIFY
SIMPLIFY
90156004 not registered Live/Pending
International Wholesale Inc
2020-09-03
SIMPLIFY
SIMPLIFY
88838510 not registered Live/Pending
Organizingbean LLC
2020-03-18
SIMPLIFY
SIMPLIFY
87924387 not registered Live/Pending
Lee, Benjamin L.
2018-05-16
SIMPLIFY
SIMPLIFY
87779370 not registered Dead/Abandoned
Welspun India Limited
2018-02-01
SIMPLIFY
SIMPLIFY
87653913 not registered Dead/Abandoned
Name Rite, L.L.C.
2017-10-20
SIMPLIFY
SIMPLIFY
87653900 not registered Dead/Abandoned
Name Rite, L.L.C.
2017-10-20
SIMPLIFY
SIMPLIFY
87653894 not registered Dead/Abandoned
Name Rite, L.L.C.
2017-10-20
SIMPLIFY
SIMPLIFY
87653888 not registered Dead/Abandoned
Name Rite, L.L.C.
2017-10-20
SIMPLIFY
SIMPLIFY
87653881 not registered Dead/Abandoned
Name Rite, L.L.C.
2017-10-20

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