Zero-P VA 04647230S

GUDID H98104647230S0

ZERO-P VA IMPLANT 10MM HEIGHT CONVEX/LARGE-STERILE

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H98104647230S0
• NIH Device Record Key: 66bfc5a2-8139-4708-aed1-7eb03c0588e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zero-P VA
• Version Model Number: 04.647.230S
• Catalog Number: 04647230S
• 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
• 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	10705034751245 [Primary]
HIBCC	H98104647230S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112068

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

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: 2015-09-14

On-Brand Devices [Zero-P VA]

• H981036479630: INSERTION DEVICE FOR ZERO-P VA
• H981SD036479640: ANGLED DRILL GUIDE WITH HANDLE ZERO-P VA
• H98104647226S0: ZERO-P VA IMPLANT 6MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647225S0: ZERO-P VA IMPLANT 5MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647222S0: ZERO-P VA IMPLANT 12MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647221S0: ZERO-P VA IMPLANT 11MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647220S0: ZERO-P VA IMPLANT 10MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647228S0: ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647227S0: ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647138S0: ZERO-P VA IMPLANT 8MM HEIGHT CONVEX-STERILE
• H98104647137S0: ZERO-P VA IMPLANT 7MM HEIGHT CONVEX-STERILE
• H98104647135S0: ZERO-P VA IMPLANT 5MM HEIGHT CONVEX-STERILE
• H98104647132S0: ZERO-P VA IMPLANT 12MM HEIGHT CONVEX-STERILE
• H98104647131S0: ZERO-P VA IMPLANT 11MM HEIGHT CONVEX-STERILE
• H98104647130S0: ZERO-P VA IMPLANT 10MM HEIGHT CONVEX-STERILE
• H98104647129S0: ZERO-P VA IMPLANT 9MM HEIGHT LORDOTIC-STERILE
• H98104647128S0: ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE
• H98104647127S0: ZERO-P VA IMPLANT 7MM HEIGHT LORDOTIC-STERILE
• H98104647126S0: ZERO-P VA IMPLANT 6MM HEIGHT LORDOTIC-STERILE
• H98104647125S0: ZERO-P VA IMPLANT 5MM HEIGHT LORDOTIC-STERILE
• H98104647122S0: ZERO-P VA IMPLANT 12MM HEIGHT LORDOTIC-STERILE
• H98104647121S0: ZERO-P VA IMPLANT 11MM HEIGHT LORDOTIC-STERILE
• H98104647120S0: ZERO-P VA IMPLANT 10MM HEIGHT LORDOTIC-STERILE
• H98104647239S0: ZERO-P VA IMPLANT 9MM HEIGHT CONVEX/LARGE-STERILE
• H98104647238S0: ZERO-P VA IMPLANT 8MM HEIGHT CONVEX/LARGE-STERILE
• H98104647237S0: ZERO-P VA IMPLANT 7MM HEIGHT CONVEX/LARGE-STERILE
• H98104647236S0: ZERO-P VA IMPLANT 6MM HEIGHT CONVEX/LARGE-STERILE
• H98104647235S0: ZERO-P VA IMPLANT 5MM HEIGHT CONVEX/LARGE-STERILE
• H98104647232S0: ZERO-P VA IMPLANT 12MM HEIGHT CONVEX/LARGE-STERILE
• H98104647231S0: ZERO-P VA IMPLANT 11MM HEIGHT CONVEX/LARGE-STERILE
• H98104647230S0: ZERO-P VA IMPLANT 10MM HEIGHT CONVEX/LARGE-STERILE
• H98104647229S0: ZERO-P VA IMPLANT 9MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104647139S0: ZERO-P VA IMPLANT 9MM HEIGHT CONVEX-STERILE
• H981606470500: GRAPHIC CASE FOR ZERO-P VA AUXILIARY INSTRUMENT SET
• H981606470020: MODULE FOR TI ZERO-P VA SCREWS
• H981606470010: GRAPHIC CASE FOR ZERO-P VA INSTRUMENT & IMPLANT SET
• H98104647219S0: ZERO-P VA IMPLANT 9MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647218S0: ZERO-P VA IMPLANT 8MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647217S0: ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647216S0: ZERO-P VA IMPLANT 6MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647215S0: ZERO-P VA IMPLANT 5MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647212S0: ZERO-P VA IMPLANT 12MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647211S0: ZERO-P VA IMPLANT 11MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647210S0: ZERO-P VA IMPLANT 10MM HEIGHT PARALLEL/LARGE-STERILE
• H98104647119S0: ZERO-P VA IMPLANT 9MM HEIGHT PARALLEL-STERILE
• H98104647118S0: ZERO-P VA IMPLANT 8MM HEIGHT PARALLEL-STERILE
• H98104647117S0: ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL-STERILE
• H98104647116S0: ZERO-P VA IMPLANT 6MM HEIGHT PARALLEL-STERILE
• H98104647115S0: ZERO-P VA IMPLANT 5MM HEIGHT PARALLEL-STERILE
• H98104647112S0: ZERO-P VA IMPLANT 12MM HEIGHT PARALLEL-STERILE