ProDisc PDLMSP11S

GUDID H981PDLMSP11S0P

SUPERIOR END PLATE MEDIUM 11°-STERILE

SYNTHES (U.S.A.) LP

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: H981PDLMSP11S0P
• NIH Device Record Key: 6fbf1226-d0b9-4424-bc8e-33a34853eb34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProDisc
• Version Model Number: PDL-M-SP11S
• Catalog Number: PDLMSP11S
• 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	10705034700182 [Primary]
HIBCC	H981PDLMSP11S0P [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