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
| M248PANTAXLSET1 - PANTA XL | 2024-08-23 The PANTA XL nail set inclides instrumentation wich are used as a guide for the implantation of PANTA XL Nail system.The PANTA X |
| 10381780125891 - PANTA | 2024-08-23 The complete PANTA removal set includes instruments to be used for the removal of all PANTA nail system. |
| 10381780064381 - B-BOP | 2024-07-11 In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a gr |
| M248119580ND1 - I.CO.S® | 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h |
| M248119590ND1 - I.CO.S® | 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h |
| M248139107ND1 - METIS® | 2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im |
| M248529061ND1 - SURFIX® | 2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws. |
| 10381780043317 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
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 |
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