CROSS-FUSE™* PEEK VBR/IBF SYSTEM 35-1855-11-6
GUDID 00846468038038
VBR, Crossfuse, 11x18x55x6 spacer
Pioneer Surgical Technology, Inc.
Vertebral body prosthesis| Primary Device ID | 00846468038038 |
| NIH Device Record Key | f10c756c-b00d-4c7d-8047-8ddd9fc3ac8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CROSS-FUSE™* PEEK VBR/IBF SYSTEM |
| Version Model Number | 35-1855-11-6 |
| Catalog Number | 35-1855-11-6 |
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468035471 [Primary] |
| GS1 | 00846468038038 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133623
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
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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