Synex 495318

GUDID H9814953180

SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/28MM-40MM HEIGHT

SYNTHES (U.S.A.) LP

Vertebral body prosthesis

• Primary Device ID: H9814953180
• NIH Device Record Key: fca13bf4-234e-43ee-8240-7149a723a240
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synex
• Version Model Number: 495.318
• Catalog Number: 495318
• 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
• 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	10705034785073 [Primary]
HIBCC	H9814953180 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003836

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

[H9814953180]

Moist Heat or Steam Sterilization

Device Entry Metadata

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

On-Brand Devices [Synex]

• H9814953270: SYNEX(TM) WITH LARGE ENDPLATE -6 DEG/45MM-73MM HEIGHT
• H9814953250: SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/36MM-56MM HEIGHT
• H9814953230: SYNEX(TM) WITH LARGE ENDPLATE 20 DEG/37MM-55MM HEIGHT
• H9814953210: SYNEX(TM) WITH LARGE ENDPLATE 10 DEG/33MM-48MM HEIGHT
• H9814953200: SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/20MM-25MM HEIGHT
• H9814953190: SYNEX(TM) WITH LARGE ENDPLATE 0 DEG/31MM-46MM HEIGHT
• H9814953180: SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/28MM-40MM HEIGHT
• H9814953170: SYNEX(TM) WITH LARGE ENDPLATE 0 DEG/26MM-36MM HEIGHT
• H9814953160: SYNEX(TM) WITH LARGE ENDPLATE 0 DEG/23MM-31MM HEIGHT
• H9814953150: SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/23MM-31MM HEIGHT
• H9816900520: SYNEX(TM) SYSTEM INSTRUMENT AND IMPLANT SET GRAPHIC CASE
• H981608070100: MODULE CASE FOR SYNEX(TM) OPEN IMPLANTS
• H981048072450: SYNEX(TM) W/LRG ENDPLATE/OPEN -6 DEG/45MM-73MM HEIGHT (TI)
• H981048072370: SYNEX(TM) W/LRG ENDPLATE/OPEN 20 DEG/37MM-55MM HEIGHT (TI)
• H981048072330: SYNEX(TM) W/LRG ENDPLATE/OPEN 10 DEG/33MM-48MM HEIGHT (TI)
• H981048072310: SYNEX(TM) W/LRG ENDPLATE/OPEN 0 DEG/31MM-46MM HEIGHT (TI)
• H981048072260: SYNEX(TM) W/LRG ENDPLATE/OPEN 0 DEG/26MM-36MM HEIGHT (TI)
• H981048072230: SYNEX(TM) W/LRG ENDPLATE/OPEN 0 DEG/23MM-31MM HEIGHT (TI)
• H981048071360: SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/36MM-56MM HEIGHT (TI)
• H981048071280: SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/28MM-40MM HEIGHT (TI)
• H981048071230: SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/23MM-31MM HEIGHT (TI)
• H981048071200: SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/20MM-25MM HEIGHT (TI)