SYNFIX Evolution 03835432
GUDID 07612334154729
SYNFIX® EVOLUTION MINI-OPEN AWL
Synthes GmbH
Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable| Primary Device ID | 07612334154729 |
| NIH Device Record Key | 0e3515b4-e8fa-41be-81e3-cf68aa67b984 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SYNFIX Evolution |
| Version Model Number | 03.835.432 |
| Catalog Number | 03835432 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07612334154729 [Direct Marking] |
| GS1 | 10705034821450 [Primary] |
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 |
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
[07612334154729]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-04-27 |
| Device Publish Date | 2019-12-20 |
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 |
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