Cross-Fuse® II PEEK VBR/IBF System 38-FORK-HL
GUDID 00846468061869
IMPLANT FORK
Pioneer Surgical Technology, Inc.
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00846468061869 |
| NIH Device Record Key | f24a0624-59a6-44fb-9497-277425a62873 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cross-Fuse® II PEEK VBR/IBF System |
| Version Model Number | 38-FORK-HL |
| Catalog Number | 38-FORK-HL |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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(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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468061869 [Primary] |
FDA Product Code
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
[00846468061869]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2018-10-06 |
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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