Cross-Fuse® II PEEK VBR/IBF System 38-2650-11-12L
GUDID 00846468059569
INTERBODY FUSION DEVICE / VERTEBRAL SPACER
Pioneer Surgical Technology, Inc.
Vertebral body prosthesis| Primary Device ID | 00846468059569 |
| NIH Device Record Key | 1ad2ad65-a48d-4133-a2d2-6a3dedb0a14c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cross-Fuse® II PEEK VBR/IBF System |
| Version Model Number | 38-2650-11-12L |
| Catalog Number | 38-2650-11-12L |
| 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 | |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083031828 [Primary] |
| GS1 | 00846468059569 [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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