Prodisc L

GUDID 10705034700182

SUPERIOR END PLATE MEDIUM 11°-STERILE

Centinel Spine, Inc.

Lumbar total disc replacement prosthesis
Primary Device ID10705034700182
NIH Device Record Keya08d4305-7d4f-4a75-a9b1-ca665e146e73
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdisc L
Version Model NumberPDL-M-SP11S
Company DUNS949024850
Company NameCentinel Spine, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843193111807 [Primary]
GS110705034700182 [Previous]

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 Date2018-11-16
Device Publish Date2018-10-16

On-Brand Devices [Prodisc L]

10705034700182SUPERIOR END PLATE MEDIUM 11°-STERILE
10705034700175SUPERIOR END PLATE MEDIUM 6°-STERILE
10705034700151POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-14MM-STERILE
10705034700144POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE
10705034700137POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE
10705034700106INFERIOR END PLATE MEDIUM-STERILE
10705034700090SUPERIOR END PLATE LARGE 11°-STERILE
10705034700083SUPERIOR END PLATE LARGE 6°-STERILE
10705034700069POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE
10705034700052POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-12MM-STERILE
10705034700045POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE
00843193114983SUPERIOR ENDPLATE MEDIUM 3°-STERILE
00843193114976INFERIOR ENDPLATE MEDIUM 8°-STERILE
00843193114969INFERIOR ENDPLATE MEDIUM 3°-STERILE
00843193114952SUPERIOR ENDPLATE LARGE 3° -STERILE
00843193114945INFERIOR ENDPLATE LARGE 8°-STERILE
00843193114938INFERIOR ENDPLATE LARGE 3°-STERILE
00843193111692INFERIOR END PLATE LARGE-STERILE

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