| Primary Device ID | M24820310051 |
| NIH Device Record Key | 85f6972b-ac7d-436e-b862-e186f77a4f6b |
| Commercial Distribution Discontinuation | 2023-12-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | K2™ Hemi Toe Implant System |
| Version Model Number | 2031005 |
| Catalog Number | 2031005 |
| Company DUNS | 963856096 |
| Company Name | INTEGRA LIFESCIENCES CORPORATION |
| 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)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780279488 [Primary] |
| HIBCC | M24820310051 [Secondary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
[M24820310051]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-03-19 |
| Device Publish Date | 2018-04-10 |
| M2482032001 | K2 HEMI REAMER |
| M2482050021 | K2 HEMI BASE |
| M2482050011 | K2 HEMI LID |
| M2482050001 | K2 HEMI TRAY |
| M248201040KMI1 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
| M2482010301 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
| M2482010201 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
| M2482010101 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
| M24820310041 | K2™ Hemi Toe Implant System TOE PLATE |
| M2482030201 | K2 HEMI SHAPER SIZE 2 |
| M24820310051 | K2 HEMI GUIDE SCREW |