FDA.reportPublic FDA data

Prodisc C

Primary DI
00843193112842
Brand
Prodisc C
Company
Centinel Spine, LLC
Model
09.820.055S
Device description
PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE
Published
2018-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
P070001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070001000PRODISC TM-C TOTAL DISC REPLACEMENTCentinel Spine, LLC2007-12-17MJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034763811PreviousGS10
00843193112842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070503476381110705034763811
00843193112842008431931128428431931128420843193112842

GMDN Terms#

Term, Definition table
TermDefinition
Cervical total intervertebral disc prosthesis, modularAn implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plates to allow small movements of the adjacent vertebrae. The endplates are typically made of metal, and the core ceramic or synthetic polymer materials.

Regulatory Flags#

DUNS number
949024850
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843193111708Prodisc LPDL-L-PT10S2018-10-16
00843193111715Prodisc LPDL-L-PT12S2018-10-16
00843193111722Prodisc LPDL-L-PT14S2018-10-16
00843193111739Prodisc LPDL-L-SP06S2018-10-16
00843193111746Prodisc LPDL-L-SP11S2018-10-16
00843193111753Prodisc LPDL-M-IP00S2018-10-16
00843193111760Prodisc LPDL-M-PT10S2018-10-16
00843193111777Prodisc LPDL-M-PT12S2018-10-16
00843193111784Prodisc LPDL-M-PT14S2018-10-16
00843193111791Prodisc LPDL-M-SP06S2018-10-16
00843193111807Prodisc LPDL-M-SP11S2018-10-16
00843193112750Prodisc C09.820.025S2018-10-16
00843193112767Prodisc C09.820.026S2018-10-16
00843193112774Prodisc C09.820.027S2018-10-16
00843193112781Prodisc C09.820.035S2018-10-16
00843193112798Prodisc C09.820.036S2018-10-16
00843193112804Prodisc C09.820.037S2018-10-16
00843193112811Prodisc C09.820.045S2018-10-16
00843193112828Prodisc C09.820.046S2018-10-16
00843193112835Prodisc C09.820.047S2018-10-16

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
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
03662663082129ActivLHighridge Medical, LLCMJO2026-02-03
03662663082136ActivLHighridge Medical, LLCMJO2026-02-03
03662663082143ActivLHighridge Medical, LLCMJO2026-02-03
03662663082150ActivLHighridge Medical, LLCMJO2026-02-03
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