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 DiscNuvasive, 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
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21
00887517729071MaXcess35000172019-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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03662663082082ActivLHighridge Medical, LLCMJO2026-02-03
03662663082099ActivLHighridge Medical, LLCMJO2026-02-03
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03662663082143ActivLHighridge Medical, LLCMJO2026-02-03
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03662663082167ActivLHighridge Medical, LLCMJO2026-02-03
03662663082174ActivLHighridge Medical, LLCMJO2026-02-03
03662663082181ActivLHighridge Medical, LLCMJO2026-02-03
03662663082198ActivLHighridge Medical, LLCMJO2026-02-03
03662663082204ActivLHighridge Medical, LLCMJO2026-02-03