Cross-Fuse® II PEEK VBR/IBF System 38-2665-15-12L
GUDID 00846468059705
INTERBODY FUSION DEVICE / VERTEBRAL SPACER
Pioneer Surgical Technology, Inc.
Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage| Primary Device ID | 00846468059705 |
| NIH Device Record Key | 7d302faa-8bf2-4a6e-b8f6-c466cdd7bba8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cross-Fuse® II PEEK VBR/IBF System |
| Version Model Number | 38-2665-15-12L |
| Catalog Number | 38-2665-15-12L |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, 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 | true |
| 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(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com |
Device Dimensions
| Device Size Text, specify | 0 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083032139 [Primary] |
| GS1 | 00846468059705 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170643
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Cross-Fuse® II PEEK VBR/IBF System]
| 00846468083854 | ANGLED INSERTER |
| 00846468080846 | Angled Inserter |
| 00846468077938 | INTERBODY FUSION DEVICE / VERTEBRAL SPACER |
| 00846468077921 | INTERBODY FUSION DEVICE / VERTEBRAL SPACER |
| 00846468077914 | INTERBODY FUSION DEVICE / VERTEBRAL SPACER |
| 00846468077907 | INTERBODY FUSION DEVICE / VERTEBRAL SPACER |
| 00846468077891 | INTERBODY FUSION DEVICE / VERTEBRAL SPACER |
| 00846468077884 | INTERBODY FUSION DEVICE / VERTEBRAL SPACER |
| 00846468077877 | INTERBODY FUSION DEVICE / VERTEBRAL SPACER |
| 00846468062668 | Inserter |
| 00846468062644 | TRIAL SPACER |
| 00846468062637 | TRIAL SPACER |
| 00846468062620 | TRIAL SPACER |
| 00846468062613 | TRIAL SPACER |
| 00846468062606 | TRIAL SPACER |
| 00846468062590 | TRIAL SPACER |
| 00846468062583 | TRIAL SPACER |
| 00846468062576 | TRIAL SPACER |
| 00846468062569 | TRIAL SPACER |
| 00846468062552 | TRIAL SPACER |
| 00846468062545 | TRIAL SPACER |
| 00846468062538 | TRIAL SPACER |
| 00846468062521 | TRIAL SPACER |
| 00846468062514 | TRIAL SPACER |
| 00846468062507 | TRIAL SPACER |
| 00846468062491 | TRIAL SPACER |
| 00846468062484 | TRIAL SPACER |
| 00846468062477 | TRIAL SPACER |
| 00846468062460 | TRIAL SPACER |
| 00846468062453 | TRIAL SPACER |
| 00846468062446 | TRIAL SPACER |
| 00846468062439 | TRIAL SPACER |
| 00846468062422 | TRIAL SPACER |
| 00846468062415 | TRIAL SPACER |
| 00846468062408 | TRIAL SPACER |
| 00846468062392 | TRIAL SPACER |
| 00846468062385 | TRIAL SPACER |
| 00846468062378 | TRIAL SPACER |
| 00846468062361 | TRIAL SPACER |
| 00846468062354 | TRIAL SPACER |
| 00846468062347 | TRIAL SPACER |
| 00846468062330 | TRIAL SPACER |
| 00846468062323 | TRIAL SPACER |
| 00846468062316 | TRIAL SPACER |
| 00846468061869 | IMPLANT FORK |
| 00846468061128 | INSERTER |
| 00846468059996 | TRIAL SPACER |
| 00846468059989 | TRIAL SPACER |
| 00846468059972 | TRIAL SPACER |
| 00846468059965 | TRIAL SPACER |
Trademark Results [Cross-Fuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CROSS-FUSE 77284786 3544634 Live/Registered |
Pioneer Surgical Technology, Inc. 2007-09-20 |
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