PedFuse
GUDID 00190361034728
Pre-Lordotic Pedicle Rod CoCr Ø5.5 X 60MM
SPINEFRONTIER, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00190361034728 |
| NIH Device Record Key | 0ead94fb-3b27-4c31-ac42-f658d972895a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PedFuse |
| Version Model Number | 01-80165-5560 |
| Company DUNS | 002003243 |
| Company Name | SPINEFRONTIER, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 5.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361034728 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133153
FDA Product Code
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
Moist Heat or Steam Sterilization
[00190361034728]
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 | 2016-09-24 |
On-Brand Devices [PedFuse]
| 00190361035374 | Sliding Washer |
| 00190361035367 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 50MM |
| 00190361035350 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 45MM |
| 00190361035343 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 40MM |
| 00190361035336 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 35MM |
| 00190361035329 | CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 50MM |
| 00190361035312 | CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 45MM |
| 00190361035305 | CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 40MM |
| 00190361035299 | CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 35MM |
| 00190361035282 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 80MM |
| 00190361035275 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 75MM |
| 00190361035268 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 70MM |
| 00190361035251 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 65MM |
| 00190361035244 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 60MM |
| 00190361035237 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 55MM |
| 00190361035220 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 50MM |
| 00190361035213 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 45MM |
| 00190361035206 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 40MM |
| 00190361035190 | CANNULATED,RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 35MM |
| 00190361035183 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 55MM |
| 00190361035176 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 50MM |
| 00190361035169 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 45MM |
| 00190361035152 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 40MM |
| 00190361035145 | CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 35MM |
| 00190361035138 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 80MM |
| 00190361035121 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 75MM |
| 00190361035114 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 70MM |
| 00190361035107 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 65MM |
| 00190361035091 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 60MM |
| 00190361035084 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 55MM |
| 00190361035077 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 50MM |
| 00190361035060 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 45MM |
| 00190361035053 | CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 40MM |
| 00190361035046 | CANNULATED,RESPOND-XL SCREW ASSY, ø7.0MM X 35MM |
| 00190361035039 | CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 55MM |
| 00190361035022 | CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 50MM |
| 00190361035015 | CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 45MM |
| 00190361035008 | CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 40MM |
| 00190361034995 | CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 35MM |
| 00190361034988 | Remind Quad-H Solid 6.5x55 |
| 00190361034971 | Remind Quad-H Solid 6.5x50 |
| 00190361034964 | Remind Quad-H Solid 6.5x45 |
| 00190361034957 | Remind Quad-H Solid 6.5x40 |
| 00190361034940 | Remind Quad-H Solid 6.5x35 |
| 00190361034933 | Remind Quad-H Solid RBM 6.5x30 |
| 00190361034926 | Remind Quad-H Solid 6.5x30 |
| 00190361034919 | Remind Quad Solid 6.5x50 |
| 00190361034902 | Remind Quad Solid 6.5x45 |
| 00190361034896 | Remind Quad Solid 6.5x40 |
| 00190361034889 | Remind Quad Solid 6.5x35 |
Trademark Results [PedFuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEDFUSE 77899454 3882390 Live/Registered |
SpineFrontier, Inc. 2009-12-22 |
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