T-PAL 04812008S

GUDID H98104812008S0

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

SYNTHES (U.S.A.) LP

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: H98104812008S0
• NIH Device Record Key: cfa55d57-6e82-438d-a290-43cdec3aa0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-PAL
• Version Model Number: 04.812.008S
• Catalog Number: 04812008S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034817033 [Primary]
HIBCC	H98104812008S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151276

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2020-02-24
• Device Publish Date: 2016-06-30

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