VAN GOGH Anterior Cervical Plate System

GUDID 00841732103795

VAN GOGH Cervical Plate, 4 Level, 72mm

CTL MEDICAL CORPORATION

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00841732103795
• NIH Device Record Key: 7ae76913-5a4b-4621-8d13-46091f8aa0e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VAN GOGH Anterior Cervical Plate System
• Version Model Number: 011.4072
• Company DUNS: 080138504
• Company Name: CTL MEDICAL CORPORATION
• 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(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com

Device Dimensions

• Length: 72 Millimeter
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter
• Device Size Text, specify: 0
• Length: 72 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732103795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121078

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

[00841732103795]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-02

On-Brand Devices [VAN GOGH Anterior Cervical Plate System]

• 00841732104136: Torque Limiting Handle, AO QC, 0.3 N-m
• 00841732104129: Tap, D4.0, L20mm
• 00841732104112: Drill Bit, D2.5, L20mm
• 00841732104105: Drill Bit, D2.5, L18mm
• 00841732104099: Drill Bit, D2.5, L16mm
• 00841732104082: Drill Bit, D2.5, L14mm
• 00841732104075: Drill Bit, D2.5, L12mm
• 00841732104068: Drill Bit, D2.5, L10mm
• 00841732104051: Drill Guide, FA
• 00841732104044: Drill Guide, VA
• 00841732104037: Drill Guide, Adjustable Depth
• 00841732104020: Awl, AO Male Small QC
• 00841732104013: Temporary Fixation Pin, L=10mm
• 00841732104006: Temporary Fixation Pin, L=8mm
• 00841732103979: Offset Handle
• 00841732103962: Plate Bender
• 00841732103955: VAN GOGH Cervical Plate, 5 Level, 104mm
• 00841732103948: VAN GOGH Cervical Plate, 5 Level, 101mm
• 00841732103931: VAN GOGH Cervical Plate, 5 Level, 98mm
• 00841732103924: VAN GOGH Cervical Plate, 5 Level, 95mm
• 00841732103917: VAN GOGH Cervical Plate, 5 Level, 92mm
• 00841732103900: VAN GOGH Cervical Plate, 5 Level, 89mm
• 00841732103894: VAN GOGH Cervical Plate, 5 Level, 86mm
• 00841732103887: VAN GOGH Cervical Plate, 5 Level, 83mm
• 00841732103870: VAN GOGH Cervical Plate, 5 Level, 80mm
• 00841732103863: VAN GOGH Cervical Plate, 4 Level, 93mm
• 00841732103856: VAN GOGH Cervical Plate, 4 Level, 90mm
• 00841732103849: VAN GOGH Cervical Plate, 4 Level, 87mm
• 00841732103832: VAN GOGH Cervical Plate, 4 Level, 84mm
• 00841732103825: VAN GOGH Cervical Plate, 4 Level, 81mm
• 00841732103818: VAN GOGH Cervical Plate, 4 Level, 78mm
• 00841732103801: VAN GOGH Cervical Plate, 4 Level, 75mm
• 00841732103795: VAN GOGH Cervical Plate, 4 Level, 72mm
• 00841732103788: VAN GOGH Cervical Plate, 4 Level, 69mm
• 00841732103771: VAN GOGH Cervical Plate, 4 Level, 66mm
• 00841732103764: VAN GOGH Cervical Plate, 4 Level, 63mm
• 00841732103757: VAN GOGH Cervical Plate, 4 Level, 60mm
• 00841732103740: VAN GOGH Cervical Plate, 3 Level, 39mm, X-Lordotic
• 00841732103733: VAN GOGH Cervical Plate, 3 Level, 69mm
• 00841732103726: VAN GOGH Cervical Plate, 3 Level, 66mm
• 00841732103719: VAN GOGH Cervical Plate, 3 Level, 63mm
• 00841732103702: VAN GOGH Cervical Plate, 3 Level, 60mm
• 00841732103696: VAN GOGH Cervical Plate, 3 Level, 57mm
• 00841732103689: VAN GOGH Cervical Plate, 3 Level, 54mm
• 00841732103672: VAN GOGH Cervical Plate, 3 Level, 51mm
• 00841732103665: VAN GOGH Cervical Plate, 3 Level, 48mm
• 00841732103658: VAN GOGH Cervical Plate, 3 Level, 45mm
• 00841732103641: VAN GOGH Cervical Plate, 3 Level, 42mm
• 00841732103634: VAN GOGH Cervical Plate, 3 Level, 39mm
• 00841732103627: VAN GOGH Cervical Plate, 2 Level, 26mm, X-Lordotic