Zero-P 03617799

GUDID H981036177990

ZERO-P TRIAL SPACER/CONVEX LARGE/9MM HEIGHT

Synthes GmbH

Spinal implant trial

• Primary Device ID: H981036177990
• NIH Device Record Key: d4bd080a-c0d9-4c80-a470-6a2b24a722ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zero-P
• Version Model Number: 03.617.799
• Catalog Number: 03617799
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819389915 [Direct Marking]
GS1	10705034717135 [Primary]
HIBCC	H981036177990 [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: true
• Device Is Sterile: false

[H981036177990]

Moist Heat or Steam Sterilization

[H981036177990]

Moist Heat or Steam Sterilization

[H981036177990]

Moist Heat or Steam Sterilization

[H981036177990]

Moist Heat or Steam Sterilization

[H981036177990]

Moist Heat or Steam Sterilization

[H981036177990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-06-01
• Device Publish Date: 2015-09-14

On-Brand Devices [Zero-P]

• H981036177990: ZERO-P TRIAL SPACER/CONVEX LARGE/9MM HEIGHT
• H981036177980: ZERO-P TRIAL SPACER/CONVEX LARGE/8MM HEIGHT
• H981036177970: ZERO-P TRIAL SPACER/CONVEX LARGE/7MM HEIGHT
• H981036177960: ZERO-P TRIAL SPACER/CONVEX LARGE/6MM HEIGHT
• H981036177910: ZERO-P TRIAL SPACER/CONVEX LARGE/11MM HEIGHT
• H981036177900: ZERO-P TRIAL SPACER/CONVEX LARGE/10MM HEIGHT
• H981036177890: ZERO-P TRIAL SPACER/CONVEX 9MM HEIGHT
• H981036177880: ZERO-P TRIAL SPACER/CONVEX 8MM HEIGHT
• H981036177870: ZERO-P TRIAL SPACER/CONVEX 7MM HEIGHT
• H981036177860: ZERO-P TRIAL SPACER/CONVEX 6MM HEIGHT
• H981036177850: ZERO-P TRIAL SPACER/CONVEX 5MM HEIGHT
• H981036177820: ZERO-P TRIAL SPACER/CONVEX 12MM HEIGHT
• H981036177810: ZERO-P TRIAL SPACER/CONVEX 11MM HEIGHT
• H981036177800: ZERO-P TRIAL SPACER/CONVEX 10MM HEIGHT
• H981036177690: ZERO-P TRIAL SPACER/LORDOTIC LARGE/9MM HEIGHT
• H981036177680: ZERO-P TRIAL SPACER/LORDOTIC LARGE/8MM HEIGHT
• H981036177670: ZERO-P TRIAL SPACER/LORDOTIC LARGE/7MM HEIGHT
• H981036177660: ZERO-P TRIAL SPACER/LORDOTIC LARGE/6MM HEIGHT
• H981036177650: ZERO-P TRIAL SPACER/LORDOTIC LARGE/5MM HEIGHT
• H981036177620: ZERO-P TRIAL SPACER/LORDOTIC LARGE/12MM HEIGHT
• H981036177610: ZERO-P TRIAL SPACER/LORDOTIC LARGE/11MM HEIGHT
• H981036177600: ZERO-P TRIAL SPACER/LORDOTIC LARGE/10MM HEIGHT
• H981036177590: ZERO-P TRIAL SPACER/LORDOTIC 9MM HEIGHT
• H981036177580: ZERO-P TRIAL SPACER/LORDOTIC 8MM HEIGHT
• H981036177570: ZERO-P TRIAL SPACER/LORDOTIC 7MM HEIGHT
• H981036177560: ZERO-P TRIAL SPACER/LORDOTIC 6MM HEIGHT
• H981036177550: ZERO-P TRIAL SPACER/LORDOTIC 5MM HEIGHT
• H981036177520: ZERO-P TRIAL SPACER/LORDOTIC 12MM HEIGHT
• H981036177510: ZERO-P TRIAL SPACER/LORDOTIC 11MM HEIGHT
• H981036177500: ZERO-P TRIAL SPACER/LORDOTIC 10MM HEIGHT
• H981036177390: ZERO-P TRIAL SPACER/PARALLEL LARGE/9MM HEIGHT
• H981036177380: ZERO-P TRIAL SPACER/PARALLEL LARGE/8MM HEIGHT
• H981036177370: ZERO-P TRIAL SPACER/PARALLEL LARGE/7MM HEIGHT
• H981036177360: ZERO-P TRIAL SPACER/PARALLEL LARGE/6MM HEIGHT
• H981036177350: ZERO-P TRIAL SPACER/PARALLEL LARGE/5MM HEIGHT
• H981036177320: ZERO-P TRIAL SPACER/PARALLEL LARGE/12MM HEIGHT
• H981036177310: ZERO-P TRIAL SPACER/PARALLEL LARGE/11MM HEIGHT
• H981036177300: ZERO-P TRIAL SPACER/PARALLEL LARGE/10MM HEIGHT
• H981036177290: ZERO-P TRIAL SPACER/PARALLEL 9MM HEIGHT
• H981036177280: ZERO-P TRIAL SPACER/PARALLEL 8MM HEIGHT
• H981036177260: ZERO-P TRIAL SPACER/PARALLEL 6MM HEIGHT
• H981036177250: ZERO-P TRIAL SPACER/PARALLEL 5MM HEIGHT
• H981036177220: ZERO-P TRIAL SPACER/PARALLEL 12MM HEIGHT
• H981036177210: ZERO-P TRIAL SPACER/PARALLEL 11MM HEIGHT
• H981036177200: ZERO-P TRIAL SPACER/PARALLEL 10MM HEIGHT
• H981036177270: ZERO-P TRIAL SPACER/PARALLEL 7MM HEIGHT
• H981SD036179010: ANGLED T8 SCREWDRIVER ZERO-P WITH LEFT HANDLE
• H981SD036179000: ANGLED T8 SCREWDRIVER ZERO-P WITH RIGHT HANDLE