SKYLINE 186801022S

GUDID 10705034411880

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 22mm

Medos International Sàrl

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 10705034411880
• NIH Device Record Key: b1aa6c14-6835-4c5c-93dc-0de76d21ea17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYLINE
• Version Model Number: 186801022S
• Catalog Number: 186801022S
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034411880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132324

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-14
• Device Publish Date: 2021-06-05

On-Brand Devices [SKYLINE]

• 10705034412276: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FIVE LEVEL PLATE 80mm
• 10705034412269: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FIVE LEVEL PLATE 75mm
• 10705034412146: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 66mm
• 10705034412139: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 63mm
• 10705034412122: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 60mm
• 10705034412030: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 44mm
• 10705034412023: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 42mm
• 10705034412016: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 40mm
• 10705034411927: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 30mm
• 10705034411910: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 28mm
• 10705034411903: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 26mm
• 10705034411897: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 24mm
• 10705034411880: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 22mm
• 10705034412641: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18 mm
• 10705034412634: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 16 mm
• 10705034412627: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 14 mm
• 10705034412528: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 18mm
• 10705034412504: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 16mm
• 10705034412481: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 14mm
• 10705034412467: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 12mm
• 10705034412412: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
• 10705034412399: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 16mm
• 10705034412375: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 14mm
• 10705034412351: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 12mm
• 10705034412115: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 57mm
• 10705034412108: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 54mm
• 10705034412092: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 51mm
• 10705034412085: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 48mm
• 10705034215457: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT
• 10705034215426: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EXPANSION TIP SCREWDRIVER
• 10705034411972: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 32mm
• 10705034411835: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 12mm
• 10705034134000: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FIVE LEVEL PLATE 90mm
• 10705034133997: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FIVE LEVEL PLATE 85mm
• 10705034133980: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FIVE LEVEL PLATE 80mm
• 10705034133973: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FIVE LEVEL PLATE 75mm
• 10705034133959: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FIVE LEVEL PLATE 65mm
• 10705034133935: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FOUR LEVEL PLATE 84mm
• 10705034133867: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM FOUR LEVEL PLATE 56mm
• 10705034133836: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 60mm
• 10705034133676: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 30mm
• 10705034133652: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 26mm
• 10705034133621: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 28mm
• 10705034133607: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 24mm
• 10705034412986: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm
• 10705034412979: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 16mm
• 10705034412962: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 14mm
• 10705034412955: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 12mm
• 10705034412863: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4.0 x 18mm
• 10705034412849: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4.0 x 16mm