Zero-P 04617211S

GUDID H98104617211S0

ZERO-P IMPLANT 11MM HEIGHT PARALLEL/LARGE-STERILE

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H98104617211S0
• NIH Device Record Key: a1f39392-8ece-45b4-92dd-856186538261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zero-P
• Version Model Number: 04.617.211S
• Catalog Number: 04617211S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034742021 [Primary]
HIBCC	H98104617211S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112459

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

On-Brand Devices [Zero-P]

• H981SD036179620: ANGLED DRILL GUIDE WITH HANDLE ZERO-P
• H98104617239S0: ZERO-P IMPLANT 9MM HEIGHT CONVEX/LARGE-STERILE
• H98104617238S0: ZERO-P IMPLANT 8MM HEIGHT CONVEX/LARGE-STERILE
• H98104617237S0: ZERO-P IMPLANT 7MM HEIGHT CONVEX/LARGE-STERILE
• H98104617236S0: ZERO-P IMPLANT 6MM HEIGHT CONVEX/LARGE-STERILE
• H98104617235S0: ZERO-P IMPLANT 5MM HEIGHT CONVEX/LARGE-STERILE
• H98104617232S0: ZERO-P IMPLANT 12MM HEIGHT CONVEX/LARGE-STERILE
• H98104617231S0: ZERO-P IMPLANT 11MM HEIGHT CONVEX/LARGE-STERILE
• H98104617230S0: ZERO-P IMPLANT 10MM HEIGHT CONVEX/LARGE-STERILE
• H98104617229S0: ZERO-P IMPLANT 9MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617228S0: ZERO-P IMPLANT 8MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617227S0: ZERO-P IMPLANT 7MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617226S0: ZERO-P IMPLANT 6MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617225S0: ZERO-P IMPLANT 5MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617222S0: ZERO-P IMPLANT 12MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617221S0: ZERO-P IMPLANT 11MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617220S0: ZERO-P IMPLANT 10MM HEIGHT LORDOTIC/LARGE-STERILE
• H98104617219S0: ZERO-P IMPLANT 9MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617218S0: ZERO-P IMPLANT 8MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617217S0: ZERO-P IMPLANT 7MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617216S0: ZERO-P IMPLANT 6MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617215S0: ZERO-P IMPLANT 5MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617212S0: ZERO-P IMPLANT 12MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617211S0: ZERO-P IMPLANT 11MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617210S0: ZERO-P IMPLANT 10MM HEIGHT PARALLEL/LARGE-STERILE
• H98104617139S0: ZERO-P IMPLANT 9MM HEIGHT CONVEX-STERILE
• H98104617138S0: ZERO-P IMPLANT 8MM HEIGHT CONVEX-STERILE
• H98104617137S0: ZERO-P IMPLANT 7MM HEIGHT CONVEX-STERILE
• H98104617136S0: ZERO-P IMPLANT 6MM HEIGHT CONVEX-STERILE
• H98104617135S0: ZERO-P IMPLANT 5MM HEIGHT CONVEX-STERILE
• H98104617132S0: ZERO-P IMPLANT 12MM HEIGHT CONVEX-STERILE
• H98104617131S0: ZERO-P IMPLANT 11MM HEIGHT CONVEX-STERILE
• H98104617130S0: ZERO-P IMPLANT 10MM HEIGHT CONVEX-STERILE
• H98104617129S0: ZERO-P IMPLANT 9MM HEIGHT LORDOTIC-STERILE
• H98104617128S0: ZERO-P IMPLANT 8MM HEIGHT LORDOTIC-STERILE
• H98104617127S0: ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE
• H98104617126S0: ZERO-P IMPLANT 6MM HEIGHT LORDOTIC-STERILE
• H98104617125S0: ZERO-P IMPLANT 5MM HEIGHT LORDOTIC-STERILE
• H98104617122S0: ZERO-P IMPLANT 12MM HEIGHT LORDOTIC-STERILE
• H98104617121S0: ZERO-P IMPLANT 11MM HEIGHT LORDOTIC-STERILE
• H98104617120S0: ZERO-P IMPLANT 10MM HEIGHT LORDOTIC-STERILE
• H98104617119S0: ZERO-P IMPLANT 9MM HEIGHT PARALLEL-STERILE
• H98104617118S0: ZERO-P IMPLANT 8MM HEIGHT PARALLEL-STERILE
• H98104617117S0: ZERO-P IMPLANT 7MM HEIGHT PARALLEL-STERILE
• H98104617116S0: ZERO-P IMPLANT 6MM HEIGHT PARALLEL-STERILE
• H98104617115S0: ZERO-P IMPLANT 5MM HEIGHT PARALLEL-STERILE
• H98104617112S0: ZERO-P IMPLANT 12MM HEIGHT PARALLEL-STERILE
• H98104617111S0: ZERO-P IMPLANT 11MM HEIGHT PARALLEL-STERILE
• H98104617110S0: ZERO-P IMPLANT 10MM HEIGHT PARALLEL-STERILE
• H981606179030: TRIAL SPACER TRAY