Cross-Fuse® PEEK IBF System 35-1450-11
GUDID 00191083028972
INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
Polymeric spinal interbody fusion cage| Primary Device ID | 00191083028972 |
| NIH Device Record Key | fcd4495d-c98f-4d73-8000-5b61900374b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cross-Fuse® PEEK IBF System |
| Version Model Number | 35-1450-11 |
| Catalog Number | 35-1450-11 |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, 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 | 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 |
Device Dimensions
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083028972 [Primary] |
| GS1 | 00846468034290 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170643
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-10 |
| Device Publish Date | 2022-03-02 |
On-Brand Devices [Cross-Fuse® PEEK IBF System]
| 00191083033716 | INSERTER |
| 00191083033709 | INSERTER, MODULAR CLEANING |
| 00846468040970 | INSERTER |
| 00191083032511 | INSERTER, MODULAR CLEANING |
| 00191083032504 | INSERTER, MODULAR CLEANING |
| 00191083032498 | TRIAL SPACER |
| 00846468039349 | TRIAL SPACER |
| 00191083032474 | TRIAL SPACER |
| 00846468039325 | TRIAL SPACER |
| 00191083032405 | TRIAL SPACER |
| 00191083032344 | TRIAL SPACER |
| 00846468038991 | TRIAL SPACER |
| 00191083032276 | TRIAL SPACER |
| 00191083033747 | TRIAL CADDY |
| 00191083033686 | INSTRUMENT CASE |
| 00191083032436 | TRIAL SPACER |
| 00846468039240 | TRIAL SPACER |
| 00191083032399 | TRIAL SPACER |
| 00191083032351 | TRIAL SPACER |
| 00191083032320 | TRIAL SPACER |
| 00191083032283 | TRIAL SPACER |
| 00846468035877 | INTERBODY FUSION DEVICE |
| 00846468035860 | INTERBODY FUSION DEVICE |
| 00191083029771 | INTERBODY FUSION DEVICE |
| 00191083029757 | INTERBODY FUSION DEVICE |
| 00846468035808 | INTERBODY FUSION DEVICE |
| 00191083029719 | INTERBODY FUSION DEVICE |
| 00191083029702 | INTERBODY FUSION DEVICE |
| 00846468035754 | INTERBODY FUSION DEVICE |
| 00846468035747 | INTERBODY FUSION DEVICE |
| 00191083029634 | INTERBODY FUSION DEVICE |
| 00191083029627 | INTERBODY FUSION DEVICE |
| 00191083029603 | INTERBODY FUSION DEVICE |
| 00191083029597 | INTERBODY FUSION DEVICE |
| 00846468035686 | INTERBODY FUSION DEVICE |
| 00191083029559 | INTERBODY FUSION DEVICE |
| 00846468035648 | INTERBODY FUSION DEVICE |
| 00191083029535 | INTERBODY FUSION DEVICE |
| 00191083029528 | INTERBODY FUSION DEVICE |
| 00191083029504 | INTERBODY FUSION DEVICE |
| 00191083029498 | INTERBODY FUSION DEVICE |
| 00191083029474 | INTERBODY FUSION DEVICE |
| 00191083029467 | INTERBODY FUSION DEVICE |
| 00191083029450 | INTERBODY FUSION DEVICE |
| 00846468035532 | INTERBODY FUSION DEVICE |
| 00191083029412 | INTERBODY FUSION DEVICE |
| 00846468092634 | INTERBODY FUSION DEVICE |
| 00191083029399 | INTERBODY FUSION DEVICE |
| 00846468092627 | INTERBODY FUSION DEVICE |
| 00846468035471 | INTERBODY FUSION DEVICE |
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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