EXPEDIUM ALTALYNE VIPER 179796380S

GUDID 10705034566436

EXPEDIUM Spine System ALTALYNE ULTRA ROD PRE-CONTOURED, SHORT diameter 5.5 mm 5.5

Medos International Sàrl

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 10705034566436
• NIH Device Record Key: fbcca49b-4f10-48d8-a9a0-9cbe5ffcaf4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPEDIUM ALTALYNE VIPER
• Version Model Number: 1797-96-380S
• Catalog Number: 179796380S
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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	10705034566436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222473

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [EXPEDIUM ALTALYNE VIPER]

• 10705034566542: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX ENDS diameter 5.5 mm x 600 mm 5.5
• 10705034566535: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX AND VIPER SYSTEM END FEATURE diameter 5.5 mm x 480
• 10705034566528: EXPEDIUM Spine System ALTALYNE ULTRA ROD BEVEL ENDS diameter 5.5 mm x 480 mm 5.5
• 10705034566511: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX ENDS diameter 5.5 mm x 480 mm 5.5
• 10705034566504: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX AND VIPER SYSTEM END FEATURE diameter 5.5 mm x 300
• 10705034566498: EXPEDIUM Spine System ALTALYNE ULTRA ROD BEVEL ENDS diameter 5.5 mm x 300 mm 5.5
• 10705034566481: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX ENDS diameter 5.5 mm x 300 mm 5.5
• 10705034566474: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX ENDS diameter 5.5 mm x 120 mm 5.5
• 10705034566467: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX AND VIPER SYSTEM END FEATURE diameter 5.5 mm x 120
• 10705034566450: EXPEDIUM Spine System ALTALYNE ULTRA ROD BEVEL ENDS diameter 5.5 mm x 120 mm 5.5
• 10705034566443: EXPEDIUM Spine System ALTALYNE ULTRA ROD PRE-CONTOURED, EXTRA LONG diameter 5.5 mm 5.5
• 10705034566436: EXPEDIUM Spine System ALTALYNE ULTRA ROD PRE-CONTOURED, SHORT diameter 5.5 mm 5.5
• 10705034566429: EXPEDIUM Spine System ALTALYNE ULTRA ROD PRE-CONTOURED, MEDIUM diameter 5.5 mm 5.5
• 10705034566412: EXPEDIUM Spine System ALTALYNE ULTRA ROD PRE-CONTOURED, LONG diameter 5.5 mm 5.5
• 10705034566405: EXPEDIUM Spine System ALTALYNE ULTRA ROD BEVEL ENDS diameter 5.5 mm x 600 mm 5.5
• 10705034566399: EXPEDIUM Spine System ALTALYNE ULTRA ROD HEX AND VIPER SYSTEM END FEATURE diameter 5.5 mm x 600