VIPER 186721745

GUDID 10705034281834

VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 x 45mm

Medos International Sàrl

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034281834
• NIH Device Record Key: a920d6c5-020c-4b5b-b3d8-e9bb6e67c46c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIPER
• Version Model Number: 186721745
• Catalog Number: 186721745
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034281834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110216

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

[10705034281834]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-03
• Device Publish Date: 2015-09-24

On-Brand Devices [VIPER]

• 10705034346335: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X100 MM 5.5
• 10705034346328: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X95 MM 5.5
• 10705034346311: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X90 MM 5.5
• 10705034358413: VIPER SYSTEM CANNULATED TAP 12MM 40-130MM +/- 0.75% 5.5
• 10705034358406: VIPER SYSTEM CANNULATED TAP 11MM 40-130MM +/- 0.75% 5.5
• 10705034346496: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X100 MM 5.5
• 10705034346489: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X95 MM 5.5
• 10705034346472: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X90 MM 5.5
• 10705034346465: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X85 MM 5.5
• 10705034346458: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X80 MM 5.5
• 10705034346441: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X75 MM 5.5
• 10705034346434: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X70 MM 5.5
• 10705034346427: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X65 MM 5.5
• 10705034346410: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 12X60 MM 5.5
• 10705034346403: Viper System Polyaxial Fully Threaded Screw 12 X 55mm 5.5
• 10705034346397: Viper System Polyaxial Fully Threaded Screw 12 X 50mm 5.5
• 10705034346380: Viper System Polyaxial Fully Threaded Screw 12 X 45mm 5.5
• 10705034346373: Viper System Polyaxial Fully Threaded Screw 12 X 40mm 5.5
• 10705034346304: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X85 MM 5.5
• 10705034346298: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X80 MM 5.5
• 10705034346281: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X75 MM 5.5
• 10705034346274: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X70 MM 5.5
• 10705034346267: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X65 MM 5.5
• 10705034346250: VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 11X60 MM 5.5
• 10705034346243: Viper System Polyaxial Fully Threaded Screw 11 X 55mm 5.5
• 10705034346236: Viper System Polyaxial Fully Threaded Screw 11 X 50mm 5.5
• 10705034346229: Viper System Polyaxial Fully Threaded Screw 11 X 45mm 5.5
• 10705034346212: Viper System Polyaxial Fully Threaded Screw 11 X 40mm 5.5
• 10705034477695: VIPER SYSTEM CORTICAL FIX X-TAB TRAY 5.5
• 10705034477510: UNIVERSAL NAVIGATION VIPER SYSTEM TRAY
• 10705034472379: UNIVERSAL NAVIGATION VIPER SYSTEM GRAPHIC CASE
• 10705034388649: VIPER SYSTEM VIPER IGS ALPHA CASE FOR USE WITH BRAINLAB
• 10705034358727: VIPER SYSTEM SCREW CADDY 5.5 8.0mm
• 10705034358710: VIPER SYSTEM SCREW CADDY 5.5 7.0mm
• 10705034358703: VIPER SYSTEM SCREW CADDY 5.5 6.0mm
• 10705034358697: VIPER SYSTEM SCREW CADDY 5.5 5.0mm
• 10705034301617: VIPER SYSTEM MIS FENESTRATED INSTRUMENT TRAY 5.5
• 10705034301266: VIPER SYSTEM CASE 5.5
• 10705034300252: VIPER F2 FACET FIXATION SYSTEM TRAY 01
• 10705034195216: VIPER F2 FACET FIXATION SYSTEM CADDY
• 10705034195209: VIPER F2 FACET FIXATION SYSTEM TRAY
• 10705034238357: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 110mm
• 10705034238333: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 100mm
• 10705034238319: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 90mm
• 10705034238302: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 85mm
• 10705034238296: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 80mm
• 10705034238289: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 75mm
• 10705034238272: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 70mm
• 10705034238265: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 65mm
• 10705034238258: VIPER 2 SYSTEM ROD PRE-LORDOSED 5.5 x 60mm