PYRAMESH® Implant System

GUDID 00721902973048

25MM X 150MM CURVED ROUND MESH

MEDTRONIC SOFAMOR DANEK, INC.

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

• Primary Device ID: 00721902973048
• NIH Device Record Key: 48a88aa4-1ae5-4f66-a6f8-e0b2287569c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYRAMESH® Implant System
• Version Model Number: X905-904
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902973048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923419

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00721902973048]

Moist Heat or Steam Sterilization

[00721902973048]

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: 2015-08-05

On-Brand Devices [PYRAMESH® Implant System]

• 00613994133038: CYLINDER X110531332 ROUND MESH 13X32
• 00681490844420: PYRAMESH 14 X 10 X 24MM
• 00681490844413: PYRAMESH 12 X 10 X 24MM
• 00681490844406: PYRAMESH 10 X 10 X 24MM
• 00681490844390: PYRAMESH 8 X 10 X 24MM
• 00681490844383: MESH 9050020 PYRAMESH 20MM
• 00681490844376: MESH 9050018 PYRAMESH 18MM
• 00681490844369: MESH 9050016 PYRAMESH 16MM
• 00681490844352: MESH 9050014 PYRAMESH 14MM
• 00681490844345: PYRAMESH 12MM
• 00681490484756: MESH 9052830 PYRAMESH IMP 22MMX28MMX30MM
• 00681490484749: MESH 9052815 PYRAMESH IMP 22MMX28MMX15MM
• 00681490484732: MESH 9052518 PYRMSH IMPL 25MM AGL 13X18
• 00681490484718: MESH 9052318 PYMSH IMPL 23X27 AGL 13X18
• 00681490484701: MESH 9052315 PYMSH IMPL 23X27 AGL 10X15
• 00681490484664: MESH 9052230 PYRAMESH IMPLT 22MMX30MM RD
• 00681490484640: MESH 9052215 PYRAMESH IMPLT 22MMX15MM RD
• 00681490484633: MESH 9052208 PYRMSH IMPL 22MM AGL 13X18
• 00681490484626: MESH 9052205 PYRMSH IMPL 22MM AGL 10X15
• 00681490484619: MESH 9051918 PYRMSH IMPL 19MM AGL 13X18
• 00681490484602: MESH 9051915 PYRMSH IMPL 19MM AGL 10X15
• 00681490484541: MESH 9051715 PYRAMESH IMP 17MMX22MMX15MM
• 00681490484534: MESH 9051710 PYRAMESH IMP 17MMX22MMX10MM
• 00681490484497: MESH 9051315 PYRM IMPLANT 13MMX15MM RND
• 00681490484480: MESH 9051314 PYRM IMPLANT 13MMX14MM RND
• 00681490484473: MESH 9051050 PYRAMESH IMP 10MMX50MM RND
• 00681490484466: MESH 9051014 PYRM IMPLANT 10MMX14MM RND
• 00681490484459: MESH 9051013 PYRM IMPLANT 10MMX13MM RND
• 00681490484442: MESH 9051011 PYRM IMPLANT 10MMX11MM RND
• 00681490484435: MESH 9051009 PYRM IMPLANT 10MMX 9MM RND
• 00681490484237: MESH 9050514 PYRM IMPL 13MMX17MMX14MM
• 00681490484220: MESH 9050513 PYRM IMPL 13MMX17MMX13MM
• 00681490484206: MESH 9050414 PYRM IMPL 10MMX14MMX14MM
• 00681490484190: MESH 9050413 PYRM IMPL 10MMX14MMX13MM
• 00673978081311: MESH 905-904 PYRM 25 X 150 ANGLED
• 00673978081304: MESH 905-903 PYRM 19 X 150 ANGLED
• 00673978081298: MESH 905-902 PYRM 10X14 OVOIDX130MM CRV
• 00673978081281: MESH 905-901 PYRM 13MM X 130MM CURVED
• 00673978081106: MESH 905-615 PYRM 16MM X 15MM ROUND
• 00673978081090: MESH 905-612 PYRM 16MM X 12MM ROUND
• 00673978081083: MESH 905-611 PYRM 16MM X 11MM ROUND
• 00673978081076: MESH 905-609 PYRM 16MM X 9MM ROUND
• 00673978081069: MESH 905-608 PYRM 16MM X 8MM ROUND
• 00673978081052: MESH 905-520 PYRM 13 X 17 OVOID X 20MM
• 00673978081045: MESH 905-515 PYRM 13 X 17 OVOID X 15MM
• 00673978081038: MESH 905-512 PYRM 13 X 17 OVOID X 12MM
• 00673978081021: MESH 905-511 PYRM 13 X 17 OVOID X 11MM
• 00673978081014: MESH 905-509 PYRM 13 X 17 OVOID X 9MM
• 00673978081007: MESH 905-508 PYRM 13 X 17 OVOID X 8MM
• 00673978080970: MESH 905-501 PYRM 13 X17 X 10 OVOID