CROSS-FUSE™* PEEK VBR/IBF SYSTEM 35-1855-9-6
GUDID 00846468038113
VBR, Crossfuse, 9x18x55x6 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 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 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| Primary Device ID | 00846468038113 |
| NIH Device Record Key | 241dbdc0-f1fa-4da3-8e59-77216584a860 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CROSS-FUSE™* PEEK VBR/IBF SYSTEM |
| Version Model Number | 35-1855-9-6 |
| Catalog Number | 35-1855-9-6 |
| 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(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468035556 [Primary] |
| GS1 | 00846468038113 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133623
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2015-12-21 |
On-Brand Devices [CROSS-FUSE™* PEEK VBR/IBF SYSTEM]
| 00846468038458 | 22X55X9MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038441 | 22X55X9MM CROSSFUSE IMPLANTS |
| 00846468038434 | 22X55X15MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038427 | 22X55X15MM CROSSFUSE IMPLANTS |
| 00846468038410 | 22X55X13MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038403 | 22X55X13MM CROSSFUSE IMPLANTS |
| 00846468038397 | 22X55X11MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038380 | 22X55X11MM CROSSFUSE IMPLANTS |
| 00846468038373 | 22X50X9MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038366 | 22X50X9MM CROSSFUSE IMPLANTS |
| 00846468038359 | 22X50X15MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038342 | 22X50X15MM CROSSFUSE IMPLANTS |
| 00846468038335 | 22X50X13MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038328 | 22X50X13MM CROSSFUSE IMPLANTS |
| 00846468038311 | 22X50X11MM 6 DEGREE CROSSFUSE IMPLANTS |
| 00846468038304 | 22X50X11MM CROSSFUSE IMPLANTS |
| 00846468038298 | 22X45X9MM 6DEGREE CROSSFUSE IMPLANTS |
| 00846468038281 | 22X45X9MM CROSSFUSE IMPLANTS |
| 00846468038274 | 22X45X15MM 6DEGREE CROSSFUSE IMPLANTS |
| 00846468038267 | 22X45X15MM CROSSFUSE IMPLANTS |
| 00846468038250 | 22X45X13MM 6DEGREE CROSSFUSE IMPLANTS |
| 00846468038243 | 22X45X13MM CROSSFUSE IMPLANTS |
| 00846468038236 | 22X45X11MM 6DEGREE CROSSFUSE IMPLANTS |
| 00846468038229 | 22X45X11MM CROSSFUSE IMPLANTS |
| 00846468038212 | Crossfuse, 9x18x60x6 spacer |
| 00846468038205 | Crossfuse, 9x18x60x0 spacer |
| 00846468038199 | Crossfuse, 17x18x60x6 spacer |
| 00846468038182 | Crossfuse, 17x18x60x0 spacer |
| 00846468038175 | Crossfuse, 15x18x60x6 spacer |
| 00846468038168 | Crossfuse, 15x18x60x0 spacer |
| 00846468038151 | Crossfuse, 13x18x60x6 spacer |
| 00846468038144 | Crossfuse, 13x18x60x0 spacer |
| 00846468038137 | Crossfuse, 11x18x60x6 spacer |
| 00846468038120 | Crossfuse, 11x18x60x0 spacer |
| 00846468038113 | VBR, Crossfuse, 9x18x55x6 spacer |
| 00846468038106 | VBR, Crossfuse, 9x18x55x0 spacer |
| 00846468038090 | VBR, Crossfuse, 17x18x55x6 spacer |
| 00846468038083 | VBR, Crossfuse, 17x18x55x0 spacer |
| 00846468038076 | VBR, Crossfuse, 15x18x55x6 spacer |
| 00846468038069 | VBR, Crossfuse, 15x18x55x0 spacer |
| 00846468038052 | VBR, Crossfuse, 13x18x55x6 spacer |
| 00846468038045 | VBR, Crossfuse, 13x18x55x0 spacer |
| 00846468038038 | VBR, Crossfuse, 11x18x55x6 spacer |
| 00846468038021 | VBR, Crossfuse, 11x18x55x0 spacer |
| 00846468038014 | VBR, Crossfuse, 9x18x50x6 spacer |
| 00846468038007 | VBR, Crossfuse, 9x18x50x0 spacer |
| 00846468037994 | VBR, Crossfuse, 17x18x50x6 spacer |
| 00846468037987 | VBR, Crossfuse, 17x18x50x0 spacer |
| 00846468037970 | VBR, Crossfuse, 15x18x50x6 spacer |
| 00846468037963 | VBR, Crossfuse, 15x18x50x0 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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