SYNFIX Evolution 08815363S

GUDID H98108815363S0

SYNFIX® EVOLUTION SPACER LARGE/13.5MM HEIGHT/18°-STER

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H98108815363S0
• NIH Device Record Key: f3879111-1b51-4839-a66f-cff101df14db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNFIX Evolution
• Version Model Number: 08.815.363S
• Catalog Number: 08815363S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: true
• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• 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
• 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	10705034814605 [Primary]
HIBCC	H98108815363S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150673

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

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: 2020-09-14
• Device Publish Date: 2016-06-30

On-Brand Devices [SYNFIX Evolution]

• H9810483523002S: SYNFIX® EVOLUTION SCREW/30MM STERILE
• H9810483522502S0: SYNFIX® EVOLUTION SCREW/25MM STERILE
• H9810483522002S0: SYNFIX® EVOLUTION SCREW/20MM STERILE
• H9810483513002S0: SYNFIX® EVOLUTION FINE TIP SCREW/30MM - STERILE
• H9810483512502S0: SYNFIX® EVOLUTION FINE TIP SCREW/25MM - STERILE
• H9810483512002S0: SYNFIX® EVOLUTION FINE TIP SCREW/20MM - STERILE
• 07611819682672: SCREW LOADING STATION FOR SYNFIX® EVOLUTION
• 07611819682719: SYNFIX® EVOLUTION TRIAL SPACER HOLDER
• H98108815356S0: SYNFIX® EVOLUTION SPACER LG DEEP/19MM HEIGHT/14°-STER
• H98108815355S0: SYNFIX® EVOLUTION SPACER LG DEEP/17MM HEIGHT/14°-STER
• H98108815354S0: SYNFIX® EVOLUTION SPACER LG DEEP/15MM HEIGHT/14°-STER
• H98108815353S0: SYNFIX® EVOLUTION SPACER LG DEEP/13.5MM HEIGHT/14°-STER
• H98108815352S0: SYNFIX® EVOLUTION SPACER LG DEEP/12MM HEIGHT/14°-STER
• H98108815346S0: SYNFIX® EVOLUTION SPACER LG DEEP/19MM HEIGHT/10°-STER
• H98108815345S0: SYNFIX® EVOLUTION SPACER LG DEEP/17MM HEIGHT/10°-STER
• H98108815344S0: SYNFIX® EVOLUTION SPACER LG DEEP/15MM HEIGHT/10°-STER
• H98108815343S0: SYNFIX® EVOLUTION SPACER LG DEEP/13.5MM HEIGHT/10°-STER
• H98108815342S0: SYNFIX® EVOLUTION SPACER LG DEEP/12MM HEIGHT/10°-STER
• H98108815341S0: SYNFIX® EVOLUTION SPACER LG DEEP/10.5MM HEIGHT/10°-STER
• H98108815336S0: SYNFIX® EVOLUTION SPACER LG DEEP/19MM HEIGHT/6°-STER
• H98108815335S0: SYNFIX® EVOLUTION SPACER LG DEEP/17MM HEIGHT/6°-STER
• H98108815334S0: SYNFIX® EVOLUTION SPACER LG DEEP/15MM HEIGHT/6°-STER
• H98108815333S0: SYNFIX® EVOLUTION SPACER LG DEEP/13.5MM HEIGHT/6°-STER
• H98108815332S0: SYNFIX® EVOLUTION SPACER LG DEEP/12MM HEIGHT/6°-STER
• H98108815331S0: SYNFIX® EVOLUTION SPACER LG DEEP/10.5MM HEIGHT/6°-STER
• H98108815365S0: SYNFIX® EVOLUTION SPACER LARGE/17MM HEIGHT/18°-STER
• H98108815364S0: SYNFIX® EVOLUTION SPACER LARGE/15MM HEIGHT/18°-STER
• H98108815363S0: SYNFIX® EVOLUTION SPACER LARGE/13.5MM HEIGHT/18°-STER
• H98108815226S0: SYNFIX® EVOLUTION SPACER MED/19MM HEIGHT/14°-STERILE
• H98108815225S0: SYNFIX® EVOLUTION SPACER MED/17MM HEIGHT/14°-STERILE
• H98108815224S0: SYNFIX® EVOLUTION SPACER MED/15MM HEIGHT/14°-STERILE
• H98108815223S0: SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/14°-STERILE
• H98108815222S0: SYNFIX® EVOLUTION SPACER MED/12MM HEIGHT/14°-STERILE
• H98108815216S0: SYNFIX® EVOLUTION SPACER MED/19MM HEIGHT/10°-STERILE
• H98108815215S0: SYNFIX® EVOLUTION SPACER MED/17MM HEIGHT/10°-STERILE
• H98108815214S0: SYNFIX® EVOLUTION SPACER MED/15MM HEIGHT/10°-STERILE
• H98108815213S0: SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/10°-STERILE
• H98108815212S0: SYNFIX® EVOLUTION SPACER MED/12MM HEIGHT/10°-STERILE
• H98108815211S0: SYNFIX® EVOLUTION SPACER MED/10.5MM HEIGHT/10°-STERILE
• H98108815206S0: SYNFIX® EVOLUTION SPACER MED/19MM HEIGHT/6°-STERILE
• H98108815205S0: SYNFIX® EVOLUTION SPACER MED/17MM HEIGHT/6°-STERILE
• H98108815204S0: SYNFIX® EVOLUTION SPACER MED/15MM HEIGHT/6°-STERILE
• H98108815203S0: SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/6°-STERILE
• H98108815202S0: SYNFIX® EVOLUTION SPACER MED/12MM HEIGHT/6°-STERILE
• H98108815201S0: SYNFIX® EVOLUTION SPACER MED/10.5MM HEIGHT/6°-STERILE
• H98108815126S0: SYNFIX® EVOLUTION SPACER SMALL/19MM HEIGHT/14°-STERILE
• H98108815125S0: SYNFIX® EVOLUTION SPACER SMALL/17MM HEIGHT/14°-STERILE
• H98108815124S0: SYNFIX® EVOLUTION SPACER SMALL/15MM HEIGHT/14°-STERILE
• H98108815123S0: SYNFIX® EVOLUTION SPACER SMALL/13.5MM HEIGHT/14°-STER
• H98108815122S0: SYNFIX® EVOLUTION SPACER SMALL/12MM HEIGHT/14°-STERILE