XRL 08807302S

GUDID H98108807302S0

XRL LARGE IMPLANT-INTEGRATED 25MM-30MM HEIGHT/0 DEG-STERILE

SYNTHES (U.S.A.) LP

Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: H98108807302S0
• NIH Device Record Key: 2ea0e399-8c7e-40ab-8f6c-bacbeb36ac5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XRL
• Version Model Number: 08.807.302S
• Catalog Number: 08807302S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034755533 [Primary]
HIBCC	H98108807302S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103320

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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: 2020-02-24
• Device Publish Date: 2015-09-14

On-Brand Devices [XRL]

• H9810880730002S0: XRL LARGE ENDPLATE SCREWS- STERILE
• H9810880720002S0: XRL MEDIUM ENDPLATE SCREWS- STERILE
• H98108807345S0: XRL LARGE ENDPLATE 30MM X 40MM/20 DEG-STERILE
• H98108807344S0: XRL LARGE ENDPLATE 30MM X 40MM/15 DEG-STERILE
• H98108807343S0: XRL LARGE ENDPLATE 30MM X 40MM/10 DEG-STERILE
• H98108807342S0: XRL LARGE ENDPLATE 30MM X 40MM/5 DEG-STERILE
• H98108807341S0: XRL LARGE ENDPLATE 30MM X 40MM/0 DEG-STERILE
• H98108807335S0: XRL LARGE ENDPLATE 28MM X 33MM/20 DEG-STERILE
• H98108807334S0: XRL LARGE ENDPLATE 28MM X 33MM/15 DEG-STERILE
• H98108807333S0: XRL LARGE ENDPLATE 28MM X 33MM/10 DEG-STERILE
• H98108807332S0: XRL LARGE ENDPLATE 28MM X 33MM/5 DEG-STERILE
• H98108807331S0: XRL LARGE ENDPLATE 28MM X 33MM/0 DEG-STERILE
• H98108807325S0: XRL LARGE ENDPLATE 27MM ROUND/20 DEG-STERILE
• H98108807324S0: XRL LARGE ENDPLATE 27MM ROUND/15 DEG-STERILE
• H98108807323S0: XRL LARGE ENDPLATE 27MM ROUND/10 DEG-STERILE
• H98108807322S0: XRL LARGE ENDPLATE 27MM ROUND/5 DEG-STERILE
• H98108807321S0: XRL LARGE ENDPLATE 27MM ROUND/0 DEG-STERILE
• H98108807315S0: XRL LARGE CENTRAL BODY 106MM-121MM HEIGHT-STERILE
• H98108807314S0: XRL LARGE CENTRAL BODY 95MM-110MM HEIGHT-STERILE
• H98108807313S0: XRL LARGE CENTRAL BODY 84MM-99MM HEIGHT-STERILE
• H98108807312S0: XRL LARGE CENTRAL BODY 73MM-88MM HEIGHT-STERILE
• H98108807311S0: XRL LARGE CENTRAL BODY 62MM-77MM HEIGHT-STERILE
• H98108807310S0: XRL LARGE CENTRAL BODY 51MM-66MM HEIGHT-STERILE
• H98108807309S0: XRL LARGE CENTRAL BODY 44MM-59MM HEIGHT-STERILE
• H98108807308S0: XRL LARGE CENTRAL BODY 37MM-52MM HEIGHT-STERILE
• H98108807307S0: XRL LARGE CENTRAL BODY 33MM-43MM HEIGHT-STERILE
• H98108807306S0: XRL LARGE CENTRAL BODY 29MM-39MM HEIGHT-STERILE
• H98108807305S0: XRL LARGE CENTRAL BODY 25MM-33MM HEIGHT-STERILE
• H98108807304S0: XRL LARGE CENTRAL BODY 22MM-27MM HEIGHT-STERILE
• H98108807303S0: XRL LARGE IMPLANT-INTEGRATED 29MM-37MM HEIGHT/0 DEG-STERILE
• H98108807302S0: XRL LARGE IMPLANT-INTEGRATED 25MM-30MM HEIGHT/0 DEG-STERILE
• H98108807301S0: XRL LARGE IMPLANT-INTEGRATED 23MM-26MM HEIGHT/0 DEG-STERILE
• H98108807246S0: XRL MEDIUM ENDPLATE 26MM X 30MM/15 DEG-STERILE
• H98108807245S0: XRL MEDIUM ENDPLATE 26MM X 30MM/10 DEG-STERILE
• H98108807244S0: XRL MEDIUM ENDPLATE 26MM X 30MM/5 DEG-STERILE
• H98108807243S0: XRL MEDIUM ENDPLATE 26MM X 30MM/0 DEG-STERILE
• H98108807242S0: XRL MEDIUM ENDPLATE 26MM X 30MM/-5 DEG-STERILE
• H98108807241S0: XRL MEDIUM ENDPLATE 26MM X 30MM/-10 DEG-STERILE
• H98108807236S0: XRL MEDIUM ENDPLATE 21MM X 24MM/15 DEG-STERILE
• H98108807235S0: XRL MEDIUM ENDPLATE 21MM X 24MM/10 DEG-STERILE
• H98108807234S0: XRL MEDIUM ENDPLATE 21MM X 24MM/5 DEG-STERILE
• H98108807233S0: XRL MEDIUM ENDPLATE 21MM X 24MM/0 DEG-STERILE
• H98108807232S0: XRL MEDIUM ENDPLATE 21MM X 24MM/-5 DEG-STERILE
• H98108807231S0: XRL MEDIUM ENDPLATE 21MM X 24MM/-10 DEG-STERILE
• H98108807224S0: XRL MEDIUM ENDPLATE 21MM ROUND/15 DEG-STERILE
• H98108807223S0: XRL MEDIUM ENDPLATE 21MM ROUND/10 DEG-STERILE
• H98108807222S0: XRL MEDIUM ENDPLATE 21MM ROUND/5 DEG-STERILE
• H98108807221S0: XRL MEDIUM ENDPLATE 21MM ROUND/0 DEG-STERILE
• H98108807215S0: XRL MEDIUM CENTRAL BODY 106MM-121MM HEIGHT-STERILE
• H98108807214S0: XRL MEDIUM CENTRAL BODY 95MM-110MM HEIGHT-STERILE