PYRAMESH® C Titanium Mesh
GUDID 00613994774651
MESH X0210022 PYR OVOID TI 13X17X70
MEDTRONIC SOFAMOR DANEK, INC.
Vertebral body prosthesis| Primary Device ID | 00613994774651 |
| NIH Device Record Key | ba82e099-fec9-49f3-b12b-f46289a676f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYRAMESH® C Titanium Mesh |
| Version Model Number | X0210022 |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
| Outer Diameter | 13 Millimeter |
| Length | 17 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994774651 [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 |
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
Moist Heat or Steam Sterilization
[00613994774651]
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 |
| 00763000855826 | MESH 9052270 PYRM IMPLANT 22MMX70MM RND |
| 00763000855727 | MESH 9051750 PYRAMESH 17MMX22MMX50MM |
Trademark Results [PYRAMESH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PYRAMESH 75334348 2242033 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1997-08-01 |
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