T-PAL 08812008

GUDID H981088120080

T-PAL SPACER 10MM X 28MM 8MM HEIGHT

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H981088120080
• NIH Device Record Key: a8302c36-0f94-4a72-b305-4383cf399e86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-PAL
• Version Model Number: 08.812.008
• Catalog Number: 08812008
• 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: 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
• 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	10705034759531 [Primary]
HIBCC	H981088120080 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100089

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

[H981088120080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-14

On-Brand Devices [T-PAL]

• H98104812216S0: T-PAL TI SPACER 12MM X 32MM 16MM HEIGHT - STERILE
• H98104812214S0: T-PAL TI SPACER 12MM X 32MM 14MM HEIGHT - STERILE
• H98104812016S0: T-PAL TI SPACER 10MM X 28MM 16MM HEIGHT - STERILE
• H98104812215S0: T-PAL TI SPACER 12MM X 32MM 15MM HEIGHT - STERILE
• H98104812213S0: T-PAL TI SPACER 12MM X 32MM 13MM HEIGHT - STERILE
• H98104812014S0: T-PAL TI SPACER 10MM X 28MM 14MM HEIGHT - STERILE
• H98104812013S0: T-PAL TI SPACER 10MM X 28MM 13MM HEIGHT - STERILE
• H98104812012S0: T-PAL TI SPACER 10MM X 28MM 12MM HEIGHT - STERILE
• H98104812010S0: T-PAL TI SPACER 10MM X 28MM 10MM HEIGHT - STERILE
• H98104812212S0: T-PAL TI SPACER 12MM X 32MM 12MM HEIGHT - STERILE
• H98104812211S0: T-PAL TI SPACER 12MM X 32MM 11MM HEIGHT - STERILE
• H98104812210S0: T-PAL TI SPACER 12MM X 32MM 10MM HEIGHT - STERILE
• H98104812209S0: T-PAL TI SPACER 12MM X 32MM 9MM HEIGHT - STERILE
• H98104812208S00: T-PAL TI SPACER 12MM X 32MM 8MM HEIGHT - STERILE
• H98104812207S0: T-PAL TI SPACER 12MM X 32MM 7MM HEIGHT - STERILE
• H98104812015S0: T-PAL TI SPACER 10MM X 28MM 15MM HEIGHT - STERILE
• H98104812011S0: T-PAL TI SPACER 10MM X 28MM 11MM HEIGHT - STERILE
• H98104812007S0: T-PAL TI SPACER 10MM X 28MM 7MM HEIGHT - STERILE
• H98104812017S0: T-PAL TI SPACER 10MM X 28MM 17MM HEIGHT - STERILE
• 10705034817040: T-PAL TI SPACER 10MM X 28MM 9MM HEIGHT - STERILE
• H98104812008S0: T-PAL TI SPACER 10MM X 28MM 8MM HEIGHT - STERILE
• H98104812217S00: T-PAL TI SPACER 12MM X 32MM 17MM HEIGHT - STERILE
• H981088122170: T-PAL SPACER 12MM X 32MM 17MM HEIGHT
• H981088122160: T-PAL SPACER 12MM X 32MM 16MM HEIGHT
• H981088122150: T-PAL SPACER 12MM X 32MM 15MM HEIGHT
• H981088122140: T-PAL SPACER 12MM X 32MM 14MM HEIGHT
• H981088122130: T-PAL SPACER 12MM X 32MM 13MM HEIGHT
• H981088122120: T-PAL SPACER 12MM X 32MM 12MM HEIGHT
• H981088122110: T-PAL SPACER 12MM X 32MM 11MM HEIGHT
• H981088122100: T-PAL SPACER 12MM X 32MM 10MM HEIGHT
• H981088122090: T-PAL SPACER 12MM X 32MM 9MM HEIGHT
• H981088122080: T-PAL SPACER 12MM X 32MM 8MM HEIGHT
• H981088122070: T-PAL SPACER 12MM X 32MM 7MM HEIGHT
• H981088120170: T-PAL SPACER 10MM X 28MM 17MM HEIGHT
• H981088120160: T-PAL SPACER 10MM X 28MM 16MM HEIGHT
• H981088120150: T-PAL SPACER 10MM X 28MM 15MM HEIGHT
• H981088120140: T-PAL SPACER 10MM X 28MM 14MM HEIGHT
• H981088120130: T-PAL SPACER 10MM X 28MM 13MM HEIGHT
• H981088120120: T-PAL SPACER 10MM X 28MM 12MM HEIGHT
• H981088120110: T-PAL SPACER 10MM X 28MM 11MM HEIGHT
• H981088120100: T-PAL SPACER 10MM X 28MM 10MM HEIGHT
• H981088120090: T-PAL SPACER 10MM X 28MM 9MM HEIGHT
• H981088120080: T-PAL SPACER 10MM X 28MM 8MM HEIGHT
• H981088120070: T-PAL SPACER 10MM X 28MM 7MM HEIGHT
• 07612334143785: T-PAL ADVANCED APPLICATOR INNER SHAFT
• 07612334143778: T-PAL ADVANCED APPLICATOR HANDLE
• 07611819416802: T-PAL SPACER REMOVER
• 07611819414624: T-PAL SPACER APPLICATOR KNOB
• 07611819414600: T-PAL SPACER APPLICATOR INNER SHAFT
• 07611819405813: T-PAL SPACER APPLICATOR HANDLE