ProDisc-C 09820045S

GUDID H98109820045S03

PRODISC-C IMPLANT LARGE 5MM-STERILE

SYNTHES (U.S.A.) LP

Cervical total disc replacement prosthesis

• Primary Device ID: H98109820045S03
• NIH Device Record Key: a003dbf7-fff3-4295-9e24-2e8937ee2756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProDisc-C
• Version Model Number: 09.820.045S
• Catalog Number: 09820045S
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034763781 [Primary]
HIBCC	H98109820045S03 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070001

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: 2020-04-06
• Device Publish Date: 2014-09-08

On-Brand Devices [ProDisc-C]

• H98109820077S08: PRODISC-C IMPLANT EXTRA LARGE DEEP 7MM-STERILE
• H98109820076S07: PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE
• H98109820075S06: PRODISC-C IMPLANT EXTRA LARGE DEEP 5MM-STERILE
• H98109820067S07: PRODISC-C IMPLANT EXTRA LARGE 7MM-STERILE
• H98109820066S06: PRODISC-C IMPLANT EXTRA LARGE 6MM-STERILE
• H98109820065S05: PRODISC-C IMPLANT EXTRA LARGE 5MM-STERILE
• H98109820057S06: PRODISC-C IMPLANT LARGE DEEP 7MM-STERILE
• H98109820056S05: PRODISC-C IMPLANT LARGE DEEP 6MM-STERILE
• H98109820055S04: PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE
• H98109820047S05: PRODISC-C IMPLANT LARGE 7MM-STERILE
• H98109820046S04: PRODISC-C IMPLANT LARGE 6MM-STERILE
• H98109820045S03: PRODISC-C IMPLANT LARGE 5MM-STERILE
• H98109820037S04: PRODISC-C IMPLANT MEDIUM DEEP 7MM-STERILE
• H98109820036S03: PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE
• H98109820035S02: PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE
• H98109820027S03: PRODISC-C IMPLANT MEDIUM 7MM-STERILE
• H98109820026S02: PRODISC-C IMPLANT MEDIUM 6MM-STERILE
• H98109820025S01: PRODISC-C IMPLANT MEDIUM 5MM-STERILE
• H981608200040: SCREW MODULE FOR PRODISC-C
• H981608200030: GRAPHIC CASE FOR PRODISC-C REMOVAL SYSTEM
• 07611819960640: GRAPHIC CASE FOR PRODISC-C(TM) INSTRUMENTS