FDA.reportPublic FDA data

Simplify® Cervical Artificial Disc

Primary DI
00843285100016
Brand
Simplify® Cervical Artificial Disc
Company
Nuvasive, Inc.
Model
A
Catalog number
SM-4L
Device description
Simplify® Cervical Artificial Disc Size SM, Height 4, 5° Lordosis
Published
2020-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJOProsthesis, Intervertebral Disc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJOProsthesis, Intervertebral DiscUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200022002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200022002Simplify® Cervical Artificial DiscGlobus Medical, Inc.2020-09-18MJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843285100016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843285100016008432851000168432851000160843285100016

GMDN Terms#

Term, Definition table
TermDefinition
Cervical total intervertebral disc replacement prosthesisAn implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is typically made of metal or synthetic polymer materials, or a combination of the two. It may be designed as a space-occupying material between two plates intended to be attached to the vertebra above and below, or as a compressible U-shaped device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Height4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-947-3472info@simplifymedical.com
+1 (858) 909-1800RA_UDI@nuvasive.com
+1 (858) 909-1800nuvainfo@globusmedical.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517127693MaXcess707042270704222026-07-27
00887517065100ACP18008223180082232026-04-25
00887517065124ACP18008312180083122026-04-25
00887517065162ACP18008316180083162026-04-25
00887517065186ACP18008318180083182026-04-25
00887517065384ACP18008512180085122026-04-25
00887517065612ACP18008622180086222026-04-25
00887517065643ACP18009117180091172026-04-25
00887517065667ACP18009119180091192026-04-25
00887517065681ACP18009121180091212026-04-25
00887517065926ACP18009229180092292026-04-25
00887517100412VuePoint897711589771152026-04-25
00887517156297ReLine11010511110105112026-04-25
00887517156822ReLine11010530110105302026-04-25
00887517378828CoRoent685121768512172026-04-25
00887517413673MAS PLIF707004270700422026-04-25
00887517645135CoRoent680050868005082026-04-25
00887517645142CoRoent680051068005102026-04-25
00887517645166CoRoent680051468005142026-04-25
00887517645173CoRoent680150868015082026-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370891BAGUERA® CSpineArt SAMJO2026-08-21
07640221370907BAGUERA® CSpineArt SAMJO2026-08-21
07640221370914BAGUERA® CSpineArt SAMJO2026-08-21
07640221370921BAGUERA® CSpineArt SAMJO2026-08-21
07640221370938BAGUERA® CSpineArt SAMJO2026-08-21
07640221370945BAGUERA® CSpineArt SAMJO2026-08-21
07640221370952BAGUERA® CSpineArt SAMJO2026-08-21
07640221370969BAGUERA® CSpineArt SAMJO2026-08-21
07640221370976BAGUERA® CSpineArt SAMJO2026-08-21
M670107731500Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107731560Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107731600Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107731660Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732500Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732560Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732600Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107732660Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733500Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733560Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733600Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733660Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
03662663082037ActivLHighridge Medical, LLCMJO2026-02-03
03662663082044ActivLHighridge Medical, LLCMJO2026-02-03
03662663082051ActivLHighridge Medical, LLCMJO2026-02-03
03662663082068ActivLHighridge Medical, LLCMJO2026-02-03
03662663082075ActivLHighridge Medical, LLCMJO2026-02-03
03662663082082ActivLHighridge Medical, LLCMJO2026-02-03
03662663082099ActivLHighridge Medical, LLCMJO2026-02-03
03662663082105ActivLHighridge Medical, LLCMJO2026-02-03
03662663082112ActivLHighridge Medical, LLCMJO2026-02-03