PYRAMESH® C Titanium Mesh

GUDID 00613994774644

MESH X0210021 PYR OVOID TI 13X17X60

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis

• Primary Device ID: 00613994774644
• NIH Device Record Key: 726d1341-11fa-4636-90eb-6dfd5c091188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYRAMESH® C Titanium Mesh
• Version Model Number: X0210021
• 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 Dimensions

• Length: 17 Millimeter
• Length: 17 Millimeter
• Length: 17 Millimeter
• Length: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994774644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011406

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00613994774644]

Moist Heat or Steam Sterilization

[00613994774644]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-09

On-Brand Devices [PYRAMESH® C Titanium Mesh]

• 00613994774675: MESH X0210024 PYR OVOID TI 13X17X90
• 00613994774668: MESH X0210023 PYR OVOID TI 13X17X80
• 00613994774651: MESH X0210022 PYR OVOID TI 13X17X70
• 00613994774644: MESH X0210021 PYR OVOID TI 13X17X60
• 00613994738691: MESH X1009461 PYR OVOID TI 13X17X50
• 00613994738684: MESH X1009460 PYR OVOID TI 13X17X40
• 00613994738677: MESH X1009459 PYR OVOID TI 13X17X30
• 00681490484787: MESH 9052890 PYRM IMPL 22MMX28MMX90MM
• 00681490484770: PYRAMESH IMPL 22MMX28MMX70MM
• 00681490484763: MESH 9052850 PYRAMESH 22MMX28MMX50MM
• 00681490484695: MESH 9052290 PYRAMESH IMP 22MMX90MM RND
• 00681490484688: MESH 9052270 PYRM IMPLANT 22MMX70MM RND
• 00681490484671: PYRAMESH IMPLANT 22MMX50MM RND
• 00681490484596: MESH 9051790 PYRM IMPL 17MMX22MMX90MM
• 00681490484589: MESH 9051770 PYRAMESH 17MMX22MMX70MM
• 00681490484572: MESH 9051750 PYRAMESH 17MMX22MMX50MM
• 00681490484565: PYRAMESH IMPL 17MMX22MMX30MM
• 00681490484527: MESH 9051690 PYRM IMPLANT 16MMX90MM RND
• 00681490484510: MESH 9051350 PYRAMESH IMP 13MMX50MM RND
• 00681490484299: MESH 9050725 PYMSH IMPL 25MM END CAP
• 00681490484282: MESH 9050722 PYMSH IMPL 22MM END CAP
• 00681490484275: MESH 9050719 PYMSH IMPL 19MM END CAP
• 00681490484268: MESH 9050716 PYMSH IMPL 16MM END CAP
• 00681490484251: MESH 9050713 PYMSH IMPL 13MM END CAP
• 00681490484213: MESH 9050450 PYRAMESH IMP 10MMX14MMX50MM
• 00673978081274: CASE 905-895 PYRAMESH INSTRUMENT
• 00721902738692: SPECIAL 7X32.5MM KIDNEY BEAN
• 00721902613760: SPECIAL 35 X 90MM MESH
• 00721902613753: SPECIAL 35 X 60MM MESH
• 00721902613739: SPECIAL 35 X 30MM MESH
• 00721902468667: STRAIGHT ANTERIOR 19 X 18/15
• 00721902468650: STRAIGHT ANTERIOR 19 X 15/12
• 00721902362521: SPECIAL 9 X 7 X 25MM MESH
• 00721902264481: MESH XIB0801-011 14MM
• 00721902264467: MESH XIB0801-009 12MM
• 00721902264436: MESH XIB0801-008 11MM
• 00721902264382: MESH XIB0801-006 9MM
• 00721902264368: MESH XIB0801-007 10MM
• 00721902264351: MESH XIB0801-005 8MM
• 00885074471648: MESH-MACH-KIDNEY-10X32X12-4
• 00885074471624: MESH-MACH-KIDNEY-10X32X11-4
• 00885074471617: MESH-MACH-KIDNEY-10X32X10-4
• 00885074471594: MESH-MACH-KIDNEY-10X32X9-4
• 00885074471587: MESH-MACH-KIDNEY-10X32X8-4
• 00885074471570: MESH-MACH-KIDNEY-10X32X7-4
• 00885074471501: MESH-MACH-KIDNEY-10X25X8-8
• 00885074471488: MESH-MACH-KIDNEY-10X25X7-8
• 20673978081148: MESH 905-800 PYRM END RING SET SCRW