LapiFix C01 N4101
GUDID 00810021865881
LapiFix K-WIRE, S. TROCAR, SMOOTH, .062 X 6", NON-STERILE
IN2BONES USA, LLC
Orthopaedic bur, reusable| Primary Device ID | 00810021865881 |
| NIH Device Record Key | 10a7a6e2-964f-4604-9779-08c3f474223f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LapiFix |
| Version Model Number | C01 N4101 |
| Catalog Number | C01 N4101 |
| 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 | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021865881 [Primary] |
FDA Product Code
| HXI | PASSER, WIRE, ORTHOPEDIC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
[00810021865881]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-12-31 |
| Device Publish Date | 2024-12-10 |
Devices Manufactured by IN2BONES USA, LLC
| 00810021860299 - AlloAid | 2025-08-04 AlloAid DIP Instrument Kit, Sterile |
| 00810021861579 - CoLink | 2025-08-04 CoLink T8 Extractor, Sterile, Single-Use |
| 00810021861586 - In2Bones | 2025-08-04 Guide Wire,Double Trocar,Smooth,.045X6 In,2-Pck,Ster,Single |
| 00810021861593 - In2Bones | 2025-08-04 Guide WIRE,Double Trocar,Smooth,.062X6 In,2-Pck,Ster,Single |
| 00810021861609 - In2Bones | 2025-08-04 Guide WIRE,Double Trocar,Smooth,.062X6 In,4-Pck,Ster,Single |
| 00810021861616 - In2Bones | 2025-08-04 Guide WIRE,Double Trocar,Smooth,.045X4 In,2-Pck,Ster,Single |
| 00810021861623 - In2Bones | 2025-08-04 Olive Wire-.045 x 2.5", 2-Pack, Sterile, Single-Use |
| 00810021861630 - In2Bones | 2025-08-04 2.0 MM Reamer, Sterile, Single-Use |
Trademark Results [LapiFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAPIFIX 88796963 not registered Live/Pending |
Treace Medical Concepts, Inc. 2020-02-13 |
 LAPIFIX 87653304 not registered Live/Pending |
In2Bones USA, LLC 2017-10-20 |
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