| Primary Device ID | 07612334268716 | 
| NIH Device Record Key | c5b78237-b004-4605-af34-4ea159600600 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | KINCISE | 
| Version Model Number | 200002202 | 
| Catalog Number | 200002202 | 
| Company DUNS | 480426451 | 
| Company Name | Synthes GmbH | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | true | 
| 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 | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 07612334268716 [Primary] | 
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
[07612334268716]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-11-04 | 
| Device Publish Date | 2024-10-25 | 
| 07612334269119 | KINCISE™ System ATTUNE™ Revision Broach Adapter | 
| 07612334268853 | KINCISE™ System Primary Hip Threaded Femoral STEM Extractor - M6 X 1mm | 
| 07612334268808 | EMPHASYS™ KINCISE™ System Stem Impactor - Offset | 
| 07612334268792 | EMPHASYS™ KINCISE™ System Stem Impactor - Straight | 
| 07612334268785 | EMPHASYS™ KINCISE™ System Straight Shell/Liner Impactor - Short | 
| 07612334268778 | EMPHASYS™ KINCISE™ System Offset Shell/Liner Impactor | 
| 07612334268761 | EMPHASYS™ KINCISE™ SYSTEM Straight Shell/Liner Impactor - Long | 
| 07612334268754 | KINCISE™ System Primary Hip Femoral Head Impactor - Shaft | 
| 07612334268747 | KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Straight | 
| 07612334268730 | KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ SUMMIT™ Stem Impactor- Straight | 
| 07612334268723 | KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Offset | 
| 07612334268716 | KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ Stem Impactor - Offset | 
| 07612334268693 | KINCISE™ System Primary Hip Femoral Broach Adapter - Straight | 
| 07612334268686 | KINCISE™ System Primary Hip Femoral Broach Adapter - Curved | 
| 07612334268655 | KINCISE™ System Manual Handle | 
| 07612334268648 | KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Short | 
| 07612334268631 | KINCISE™ System Primary Hip, Screwdriver, hexagonal, 8.0mm | 
| 07612334268624 | KINCISE™ System Primary Hip PINNACLE™ Version Guide | 
| 07612334268617 | KINCISE™ System Primary Hip PINNACLE™ Inclination Guide | 
| 07612334268600 | KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor | 
| 07612334268594 | KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long | 
| 07612334268570 | KINCISE™ System Lithium-ion Battery | 
| 07612334268563 | KINCISE™ System Automated Surgical Handpiece V2 | 
| 07612334268679 | KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE | 
| 07612334268587 | KINCISE(TM) SYSTEM STERILIZATION CASE LID | 
| 07612334260079 | KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  KINCISE  90105877  not registered Live/Pending | Depuy Synthes, Inc. 2020-08-11 | 
|  KINCISE  88032292  not registered Live/Pending | Depuy Synthes, Inc. 2018-07-10 |