SYNFIX Evolution 03835001
GUDID 07611819658097
SYNFIX® EVOLUTION AIMING DEVICE/10.5MM & 12MM
Synthes GmbH
Orthopaedic implant aiming/guiding block, reusable| Primary Device ID | 07611819658097 |
| NIH Device Record Key | 7febcc1e-be65-48b9-939e-ed7b1093d653 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SYNFIX Evolution |
| Version Model Number | 03.835.001 |
| Catalog Number | 03835001 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | false |
| 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(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819658097 [Direct Marking] |
| GS1 | 10705034814063 [Primary] |
| HIBCC | H981038350010 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150673
FDA Product Code
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
[07611819658097]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-04-27 |
| Device Publish Date | 2016-06-30 |
On-Brand Devices [SYNFIX Evolution]
| 07612334084262 | SYNFIX® EVO FOOTPRINT TRIAL LARGE/LARGE DEEP |
| 07612334084255 | SYNFIX® EVO FOOTPRINT TRIAL MEDIUM/MEDIUM DEEP |
| 07612334081643 | SYNFIX® EVO FOOTPRINT TRIAL SMALL/SMALL DEEP |
| 07612334154729 | SYNFIX® EVOLUTION MINI-OPEN AWL |
| 07612334154712 | SYNFIX® EVOLUTION MINI-OPEN SCREWDRIVER/SHORT |
| 07612334154705 | SYNFIX® EVOLUTION MINI-OPEN DRIVER W/O THREAD LOCK SLEEVE |
| 07612334154699 | SYNFIX® EVOLUTION MINI-OPEN SCREWDRIVER |
| 07612334154682 | SYNFIX® EVOLUTION MINI-OPEN AIMING DEVICE/17MM & 19MM |
| 07612334154675 | SYNFIX® EVOLUTION MINI-OPEN AIMING DEVICE/13.5MM & 15MM |
| 07612334154668 | SYNFIX® EVOLUTION MINI-OPEN AIMING DEVICE/10.5MM & 12MM |
| 10705034817538 | SYNFIX® EVOLUTION THREAD LOCK SLEEVE - STERILE |
| 07611819681293 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/6° |
| 07611819681286 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/6° |
| 07611819681279 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/6° |
| 07611819681262 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/13.5MM HEIGHT/6° |
| 07611819681255 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/12MM HEIGHT/6° |
| 07611819681248 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/10.5MM HEIGHT/6° |
| 07611819681460 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/6° |
| 07611819681453 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/6° |
| 07611819681446 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/6° |
| 07611819681521 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/10° |
| 07611819681514 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/10° |
| 07611819681507 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/10° |
| 07611819681491 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/10° |
| 07611819681439 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/6° |
| 07611819681484 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/12MM HEIGHT/10° |
| 07611819681422 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/12MM HEIGHT/6° |
| 07611819681477 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/10.5MM HEIGHT/10° |
| 07611819681354 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/10° |
| 07611819681347 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/10° |
| 07611819681330 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/10° |
| 07611819681323 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/13.5MM HEIGHT/10° |
| 07611819681316 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/12MM HEIGHT/10° |
| 07611819681309 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/10.5MM HEIGHT/10° |
| 07611819681613 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/18° |
| 07611819681606 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/18° |
| 07611819681590 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/18° |
| 07611819681583 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/13.5MM HEIGHT/18° |
| 07611819681651 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/18° |
| 07611819681644 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/18° |
| 07611819681637 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/18° |
| 07611819681620 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/18° |
| 07611819681576 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/14° |
| 07611819681569 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/14° |
| 07611819681552 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/14° |
| 07611819681545 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/14° |
| 07611819681538 | SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/12MM HEIGHT/14° |
| 07611819681408 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/14° |
| 07611819681392 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/14° |
| 07611819681385 | SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/14° |
Trademark Results [SYNFIX Evolution]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNFIX EVOLUTION 86268391 5114907 Live/Registered |
DEPUY SYNTHES, INC. 2014-05-01 |
 SYNFIX EVOLUTION 85187900 not registered Dead/Abandoned |
DEPUY SYNTHES, INC. 2010-12-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.