VENTURE™ Anterior Cervical Plate System

GUDID 00885074529615

4.0 X 12 SELF DRILL FIX SCREW

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00885074529615
• NIH Device Record Key: a8f5fc71-4c35-461c-bee3-775a132f8f56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTURE™ Anterior Cervical Plate System
• Version Model Number: 9791222
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074529615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061274

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

Moist Heat or Steam Sterilization

[00885074529615]

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: 2015-08-19

On-Brand Devices [VENTURE™ Anterior Cervical Plate System]

• 00613994404466: PLATE X0807004 ANT CERV - 90MM - 4LEV
• 00613994404459: PLATE X0807003 ANT CERV - 87.5MM - 4LEV
• 00613994305367: PLATE X0107254 ANT CERV PLT 32.5MM 1 LEV
• 00613994305350: PLATE X0107255 ANT CERV PLT 35MM 1 LEV
• 00613994305343: PLATE X0107256 ANT CERV PLT 52.5MM 2 LEV
• 00613994305336: PLATE X0107257 ANT CERV PLT 55MM 2 LEV
• 00613994305329: PLATE X0107258 ANT CERV PLT 75MM 3 LEV
• 00613994305312: PLATE X0107259 ANT CERV PLT 77.5MM 3 LEV
• 00721902989704: SCREW 9790315 4 0X15 SELF TAP VAR
• 00721902989513: SCREW 9795327 4 5X17 SELF DRILL VAR
• 00721902989490: SCREW 9795317 4 5X17 SELF TAP VAR
• 00721902989483: SCREW 9790317 4 0X17 SELF TAP VAR
• 00721902989476: SCREW 9795325 4 5X15 SELF DRILL VAR
• 00721902989469: SCREW 9790325 4 0X15 SELF DRILL VAR
• 00721902989452: SCREW 9795315 4 5X15 SELF TAP VAR
• 00721902989438: SCREW 9795323 4 5X13 SELF DRILL VAR
• 00721902989414: SCREW 9795313 4 5X13 SELF TAP VAR
• 00721902989407: SCREW 9790313 4 0X13 SELF TAP VAR
• 00721902989391: SCREW 9795227 4 5X17 SELF DRILL FIX
• 00721902989377: SCREW 9795217 4 5X17 SELF TAP FIX
• 00721902989360: SCREW 9790217 4 0X17 SELF TAP FIX
• 00721902989353: SCREW 9795225 4 5X15 SELF DRILL FIX
• 00721902989339: SCREW 9795215 4 5X15 SELF TAP FIX
• 00721902989322: SCREW 9790215 4 0X15 SELF TAP FIX
• 00721902989315: SCREW 9795223 4 5X13 SELF DRILL FIX
• 00721902989308: SCREW 9790223 4 0X13 SELF DRILL FIX
• 00721902989292: SCREW 9795213 4 5X13 SELF TAP FIX
• 00721902989278: SCREW 9790213 4 0X13 SELF TAP FIX
• 00721902989261: PLATE 9790110 ANT CERV PLATE ASSY 110MM
• 00721902989254: PLATE 9790105 ANT CERV PLATE ASSY 105MM
• 00721902989247: PLATE 9790100 ANT CERV PLATE ASSY 100MM
• 00721902989230: PLATE 9790095 ANT CERV ASSY 95MM
• 00721902989223: PLATE 9790090 ANT CERV ASSY 90MM
• 00721902989216: PLATE 9790087 ANT CERV ASSY 87 5MM
• 00721902989209: PLATE 9790085 ANT CERV ASSY 85MM
• 00721902989193: PLATE 9790082 ANT CERV ASSY 82 5MM
• 00721902989186: ASSEMBLY 9790080 CERVICAL PLATE 80MM
• 00721902989179: PLATE 9790077 ANT CERV ASSY 77 5MM
• 00721902989162: PLATE 9790075 ANT CERV ASSY 75MM
• 00721902989155: PLATE 9790072 ANT CERV ASSY 72 5MM
• 00721902989148: PLATE 9790070 ANT CERV ASSY 70MM
• 00721902989131: PLATE 9790067 ANT CERV ASSY 67 5MM
• 00721902989124: PLATE 9790065 ANT CERV ASSY 65MM
• 00721902989117: PLATE 9790062 ANT CERV ASSY 62 5MM
• 00721902989100: PLATE 9790060 ANT CERV ASSY 60MM
• 00721902989094: PLATE 9790057 ANT CERV ASSY 57 5MM
• 00721902989087: PLATE 9790055 ANT CERV ASSY 55MM
• 00721902989070: PLATE 9790052 ANT CERV ASSY 52 5MM
• 00721902989063: PLATE 9790050 ANT CERV ASSY 50MM
• 00721902989056: PLATE 9790047 ANT CERV ASSY 47 5MM