PYRAMID® +4 Anterior Lumbar Plate System

GUDID 00613994922915

PLATE X1210060 PYR FIXED TI 3HOLE 36MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00613994922915
• NIH Device Record Key: 54bdf42c-e7c3-407b-b379-252391f8f3cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYRAMID® +4 Anterior Lumbar Plate System
• Version Model Number: X1210060
• 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

Device Dimensions

• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994922915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080429

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

Moist Heat or Steam Sterilization

[00613994922915]

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: 2015-06-29

On-Brand Devices [PYRAMID® +4 Anterior Lumbar Plate System]

• 00613994927897: SCR X1010598 5.5 RED MAS TI OG 9.5X100
• 00613994923004: PLATE X1210069 PYR FIXED TI 4HOLE 46MM
• 00613994922991: PLATE X1210068 PYR FIXED TI 4HOLE 44MM
• 00613994922984: PLATE X1210067 PYR FIXED TI 4HOLE 42MM
• 00613994922977: PLATE X1210066 PYR FIXED TI 4HOLE 40MM
• 00613994922960: PLATE X1210065 PYR FIXED TI 4HOLE 38MM
• 00613994922953: PLATE X1210064 PYR FIXED TI 4HOLE 36MM
• 00613994922946: PLATE X1210063 PYR FIXED TI 3HOLE 42MM
• 00613994922939: PLATE X1210062 PYR FIXED TI 3HOLE 40MM
• 00613994922922: PLATE X1210061 PYR FIXED TI 3HOLE 38MM
• 00613994922915: PLATE X1210060 PYR FIXED TI 3HOLE 36MM
• 00613994922908: PLATE X1210059 PYR FIXED TI 3HOLE 34MM
• 00613994922892: SCR X1210089 PYR FIXED TI CANC 7.0X35
• 00613994922885: SCR X1210088 PYR FIXED TI CANC 7.0X32.5
• 00613994922878: SCR X1210087 PYR FIXED TI CANC 7.0X30
• 00613994922861: SCR X1210086 PYR FIXED TI CANC 7.0X27.5
• 00613994922854: SCR X1210085 PYR FIXED TI CANC 7.0X25
• 00613994922847: SCR X1210084 PYR FIXED TI CANC 7.0X22.5
• 00613994922830: SCR X1210083 PYR FIXED TI CANC 7.0X20
• 00613994922823: SCR X1210078 PYR FIXED TI CANC 6.5X35
• 00613994922816: SCR X1210077 PYR FIXED TI CANC 6.5X32.5
• 00613994922809: SCR X1210076 PYR FIXED TI CANC 6.5X30
• 00613994922793: SCR X1210075 PYR FIXED TI CANC 6.5X27.5
• 00613994922786: SCR X1210074 PYR FIXED TI CANC 6.5X25
• 00613994922779: SCR X1210073 PYR FIXED TI CANC 6.5X22.5
• 00613994922762: SCR X1210072 PYR FIXED TI CANC 6.5X20
• 00613994681454: SCREW X0909048 PYR TI CANC DUALLD 6.5X35
• 00613994681447: SCREW X0909047 PYR TI CANC DULD 6.5X32.5
• 00613994681430: SCREW X0909046 PYR TI CANC DUALLD 6.5X30
• 00613994681423: SCREW X0909045 PYR TI CANC DULD 6.5X27.5
• 00613994681416: SCREW X0909044 PYR TI CANC DUALLD 6.5X25
• 00613994681409: SCREW X0909043 PYR TI CANC DULD 6.5X22.5
• 00613994681393: SCREW X0909042 PYR TI CANC DUALLD 6.5X20
• 00613994607126: PLATE X0409001 X0409001
• 00613994470294: PLATE 9873141 3-HOLE 41MM
• 00613994470287: PLATE 9873139 3-HOLE 39MM
• 00613994470270: PLATE 9873137 3-HOLE 37MM
• 00613994470263: PLATE 9873135 3-HOLE 35MM
• 00613994470256: PLATE 9873133 3-HOLE 33MM
• 00613994286826: PLATE 9874045 4HOLE 45MM
• 00613994286130: PLATE 9873033 3HOLE 33MM
• 00613994286123: PLATE 9873035 3HOLE 35MM
• 00613994286116: PLATE 9873037 3HOLE 37MM
• 00613994286109: PLATE 9873039 3HOLE 39MM
• 00613994286093: PLATE 9873041 3HOLE 41MM
• 00613994286079: PLATE 9874035 4HOLE 35MM
• 00613994286062: PLATE 9874037 4HOLE 37MM
• 00613994286055: PLATE 9874039 4HOLE 39MM
• 00613994286048: PLATE 9874041 4HOLE 41MM
• 00613994286031: PLATE 9874043 4HOLE 43MM