FDA.reportPublic FDA data

Prodisc L

Primary DI
00843193111777
Brand
Prodisc L
Company
Centinel Spine, LLC
Model
PDL-M-PT12S
Device description
POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-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
P050010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050010000PRODISC -L TOTAL DISC REPLACEMENT DEVICECentinel Spine, LLC2006-08-14MJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034700144PreviousGS10
00843193111777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070503470014410705034700144
00843193111777008431931117778431931117770843193111777

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar total intervertebral disc prosthesisAn implantable device designed to replace a dysfunctional intervertebral disc in the lumbar spine. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below and may have a compressible core component between. It may facilitate some degree of motion and is typically made of metal and/or synthetic polymer materials. This is the complete prosthesis assembly, not individual components.

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
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
00843193112842Prodisc C09.820.055S2018-10-16

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
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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
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03662663082204ActivLHighridge Medical, LLCMJO2026-02-03