ANTEGRA-T 04103053S

GUDID H98104103053S0

TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-SACRAL

Synthes GmbH

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: H98104103053S0
• NIH Device Record Key: 055ef795-d078-4c7d-bf3b-68c5df6c114b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTEGRA-T
• Version Model Number: 04.103.053S
• Catalog Number: 04103053S
• 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: 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
• 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	10705034733241 [Primary]
HIBCC	H98104103053S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081568

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

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: 2022-04-26
• Device Publish Date: 2015-09-14

On-Brand Devices [ANTEGRA-T]

• H98104103053S0: TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-SACRAL
• H98104103051S0: TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-SACRAL
• H98104103049S0: TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-SACRAL
• H98104103047S0: TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-SACRAL
• H98104103045S0: TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-SACRAL
• H98104103043S0: TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-SACRAL
• H98104103041S0: TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-SACRAL
• H98104103039S0: TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-SACRAL
• H98104103037S0: TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-SACRAL
• H98104102053S0: TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-LUMBAR
• H98104102051S0: TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-LUMBAR
• H98104102049S0: TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-LUMBAR
• H98104102047S0: TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-LUMBAR
• H98104102045S0: TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-LUMBAR
• H98104102043S0: TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-LUMBAR
• H98104102041S0: TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-LUMBAR
• H98104102039S0: TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-LUMBAR
• H98104102037S0: TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-LUMBAR
• H981036611390: TRIAL ANTEGRA-T PLATE LUMBAR/53MM
• H981036611380: TRIAL ANTEGRA-T PLATE LUMBAR/51MM
• H981036611370: TRIAL ANTEGRA-T PLATE LUMBAR/49MM
• H981036611360: TRIAL ANTEGRA-T PLATE LUMBAR/47MM
• H981036611350: TRIAL ANTEGRA-T PLATE LUMBAR/45MM
• H981036611340: TRIAL ANTEGRA-T PLATE LUMBAR/43MM
• H981036611330: TRIAL ANTEGRA-T PLATE LUMBAR/41MM
• H981036611320: TRIAL ANTEGRA-T PLATE LUMBAR/39MM
• H981036611310: TRIAL ANTEGRA-T PLATE LUMBAR/37MM
• H981036611090: TRIAL ANTEGRA-T PLATE SACRAL/53MM
• H981036611080: TRIAL ANTEGRA-T PLATE SACRAL/51MM
• H981036611070: TRIAL ANTEGRA-T PLATE SACRAL/49MM
• H981036611060: TRIAL ANTEGRA-T PLATE SACRAL/47MM
• H981036611050: TRIAL ANTEGRA-T PLATE SACRAL/45MM
• H981036611040: TRIAL ANTEGRA-T PLATE SACRAL/43MM
• H981036611030: TRIAL ANTEGRA-T PLATE SACRAL/41MM
• H981036611020: TRIAL ANTEGRA-T PLATE SACRAL/39MM
• H981036611010: TRIAL ANTEGRA-T PLATE SACRAL/37MM
• H981SD036611250: ANTEGRA-T TEMPORARY FIXATION PIN-EXTRA LONG
• H981SD031610530: ANTEGRA-T AWL-EXTRA LONG