K-FIX®
GUDID 00381780357493
The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three main functions in foot surgery for protruding wires. It protects patients and/or hospital staff from wire sharp ends. It prevents any inward pin migration as well as reducing bandage size. It allows easy removal of the wire by the surgeon. Its fixation requires no instrument. The protector ball is introduced until firm locking on the wire extremity previously bent.
NEWDEAL
Surgical instrument guard, single-use, sterile| Primary Device ID | 00381780357493 |
| NIH Device Record Key | a8da6ddf-7fac-486f-b2b6-b6cfe006bc9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-FIX® |
| Version Model Number | 119050ND |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| Device Count | 5 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381780357493 [Unit of Use] |
| GS1 | 10381780045885 [Previous] |
| GS1 | 10381780357490 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022597
FDA Product Code
| HTY | PIN, FIXATION, SMOOTH |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-01 |
| Device Publish Date | 2020-11-23 |
Devices Manufactured by NEWDEAL
| M248119510ND1 - I.CO.S® | 2025-04-28 The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed s |
| M248119511ND1 - I.CO.S® | 2025-04-28 The measurer is used to measure the 250mm K-wire in place and decide the compression screw length to implant. It is placed so th |
| M248119532ND1 - I.CO.S® | 2025-04-28 The cannulated graduated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to power implant the 4.0mm compre |
| M248119536ND1 - I.CO.S® | 2025-04-28 The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i |
| M248119562ND1 - I.CO.S® | 2025-04-28 The cannulated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to implant the 6.5mm compression screws. It |
| M248119566ND1 - I.CO.S® | 2025-04-28 The cannulated external screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i |
| 10381780045892 - IPP-ON | 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis |
| 10381780045908 - IPP-ON | 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis |
Trademark Results [K-FIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K-FIX 78078611 2626747 Dead/Cancelled |
NEWDEAL 2001-08-10 |
 K-FIX 77334596 3467082 Dead/Cancelled |
Paradigm Agricultural Consulting, Inc. 2007-11-20 |
 K-FIX 75768474 2426391 Dead/Cancelled |
Paradigm Agricultural Consulting, Inc. 1999-10-30 |
 K-FIX 75120416 not registered Dead/Abandoned |
Kinetikos Medical, Inc. 1996-06-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.