ZERO-P NATURAL 03617038

GUDID 07612334096968

ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/8MM

Synthes GmbH

Spinal implant trial

• Primary Device ID: 07612334096968
• NIH Device Record Key: 5513783f-7f72-4ee2-8a01-f0481071f7e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERO-P NATURAL
• Version Model Number: 03.617.038
• Catalog Number: 03617038
• 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	07612334096968 [Direct Marking]
GS1	10705034811963 [Primary]
HIBCC	H981036170380 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152239

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07612334096968]

Moist Heat or Steam Sterilization

[07612334096968]

Moist Heat or Steam Sterilization

[07612334096968]

Moist Heat or Steam Sterilization

[07612334096968]

Moist Heat or Steam Sterilization

[07612334096968]

Moist Heat or Steam Sterilization

[07612334096968]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-05-27
• Device Publish Date: 2017-02-17

On-Brand Devices [ZERO-P NATURAL]

• H98103617014S0: ZERO-P NATURAL ASSEMBLY TOOL STERILE
• 07612334096906: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/10MM
• 07612334096722: ZERO-P NATURAL TRIAL SPACER PARALLEL/10MM
• H98104617712S0: ZERO-P NATURAL PLATE SIZE 12 WITH ASSEMBLY TOOL-STERILE
• H98104617711S0: ZERO-P NATURAL PLATE SIZE 11 WITH ASSEMBLY TOOL-STERILE
• H98104617710S0: ZERO-P NATURAL PLATE SIZE 10 WITH ASSEMBLY TOOL-STERILE
• H98104617709S0: ZERO-P NATURAL PLATE SIZE 9 WITH ASSEMBLY TOOL-STERILE
• H98104617708S0: ZERO-P NATURAL PLATE SIZE 8 WITH ASSEMBLY TOOL-STERILE
• H98104617707S0: ZERO-P NATURAL PLATE SIZE 7 WITH ASSEMBLY TOOL-STERILE
• H98104617706S0: ZERO-P NATURAL PLATE SIZE 6 WITH ASSEMBLY TOOL-STERILE
• 07612334097132: ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/9MM
• 07612334097125: ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/8MM
• 07612334097118: ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/7MM
• 07612334097101: ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/6MM
• 07612334097088: ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/12MM
• 07612334097071: ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/11MM
• 07612334097064: ZERO-P NATURAL TRIAL SPACER LORDOTIC/LARGE/10MM
• 07612334097057: ZERO-P NATURAL TRIAL SPACER LORDOTIC/9MM
• 07612334097040: ZERO-P NATURAL TRIAL SPACER LORDOTIC/8MM
• 07612334097033: ZERO-P NATURAL TRIAL SPACER LORDOTIC/7MM
• 07612334097026: ZERO-P NATURAL TRIAL SPACER LORDOTIC/6MM
• 07612334097002: ZERO-P NATURAL TRIAL SPACER LORDOTIC/12MM
• 07612334096999: ZERO-P NATURAL TRIAL SPACER LORDOTIC/11MM
• 07612334096982: ZERO-P NATURAL TRIAL SPACER LORDOTIC/10MM
• 07612334096975: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/9MM
• 07612334096968: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/8MM
• 07612334096951: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/7MM
• 07612334096944: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/6MM
• 07612334096920: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/12MM
• 07612334096913: ZERO-P NATURAL TRIAL SPACER PARALLEL/LARGE/11MM
• 07612334096890: ZERO-P NATURAL TRIAL SPACER PARALLEL/9MM
• 07612334096883: ZERO-P NATURAL TRIAL SPACER PARALLEL/8MM
• 07612334096876: ZERO-P NATURAL TRIAL SPACER PARALLEL/7MM
• 07612334096869: ZERO-P NATURAL TRIAL SPACER PARALLEL/6MM
• 07612334096746: ZERO-P NATURAL TRIAL SPACER PARALLEL/12MM
• 07612334096739: ZERO-P NATURAL TRIAL SPACER PARALLEL/11MM