Prodisc L

GUDID 10705034700106

INFERIOR END PLATE MEDIUM-STERILE

Centinel Spine, Inc.

Lumbar total disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc replacement prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis Lumbar total intervertebral disc prosthesis

• Primary Device ID: 10705034700106
• NIH Device Record Key: 27fe711a-216c-44f0-a7b0-85fc58940fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodisc L
• Version Model Number: PDL-M-IP00S
• Company DUNS: 949024850
• Company Name: Centinel Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843193111753 [Primary]
GS1	10705034700106 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050010

FDA Product Code

• MJO: Prosthesis, Intervertebral Disc

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-16
• Device Publish Date: 2018-10-16

On-Brand Devices [Prodisc L]

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