| Primary Device ID | 00810021866536 |
| NIH Device Record Key | a85021b7-c5b5-4bc9-acf2-73419a5f0c6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink LapiFix |
| Version Model Number | C01 N4012 |
| Catalog Number | C01 N4012 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| 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(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021866536 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
[00810021866536]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 03701337600778 - QUANTUM | 2024-12-23 QUANTUM Impaction Frame Tibial Implant |
| 03701337600792 - QUANTUM | 2024-12-23 QUANTUM Handle For Impaction Frame |
| 03701337600808 - QUANTUM | 2024-12-23 QUANTUM Shaper For Tibial Stem |
| 03701337601096 - QUANTUM | 2024-12-23 QUANTUM Pin Pusher |
| 03701337617967 - QUANTUM | 2024-12-23 QUANTUM IMPACTOR FRAME QUICK COUPLING |
| 00810021861050 - In2Bones | 2024-12-20 LOCKING DRILL GUIDE, 2.3 MM, NON-STERILE |
| 00810021861067 - In2Bones | 2024-12-20 LOCKING DRILL GUIDE, 2.8 MM, NON-STERILE |
| 00810021861449 - IBS-B | 2024-12-20 IBS-B MIS Compression Screw,Dia.3.3x52mm |