ProDisc PDLMPT12S

GUDID H981PDLMPT12S0R

POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE

SYNTHES (U.S.A.) LP

Lumbar total intervertebral disc replacement prosthesis

• Primary Device ID: H981PDLMPT12S0R
• NIH Device Record Key: 1e30026d-8f13-4f15-9ea2-a0053d17d30f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProDisc
• Version Model Number: PDL-M-PT12S
• Catalog Number: PDLMPT12S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034700144 [Primary]
HIBCC	H981PDLMPT12S0R [Secondary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-06
• Device Publish Date: 2017-02-17

On-Brand Devices [ProDisc]

• H981PDLMSP11S0P: SUPERIOR END PLATE MEDIUM 11°-STERILE
• H981PDLMSP06S0T: SUPERIOR END PLATE MEDIUM 6°-STERILE
• H981PDLMPT14S0T: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-14MM-STERILE
• H981PDLMPT12S0R: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE
• H981PDLMPT10S0P: POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE
• H981PDLMIP00S0D: INFERIOR END PLATE MEDIUM-STERILE
• H981PDLLSP11S0O: SUPERIOR END PLATE LARGE 11°-STERILE
• H981PDLLSP06S0S: SUPERIOR END PLATE LARGE 6°-STERILE
• H981PDLLPT14S0S: POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE
• H981PDLLPT12S0Q: POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-12MM-STERILE
• H981PDLLPT10S0O: POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE
• H981PDLLIP00S0C: INFERIOR END PLATE LARGE-STERILE