CALCANEA CALCINSTSET
GUDID 10381780125853
Full Calcanea Plate Instrument and Implant Set
NEWDEAL
General internal orthopaedic fixation system implantation kit| Primary Device ID | 10381780125853 |
| NIH Device Record Key | 74c765b7-c4b3-4977-a9c5-307f1343736b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CALCANEA |
| Version Model Number | CALCINSTSET |
| Catalog Number | CALCINSTSET |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780125853 [Primary] |
| HIBCC | M248CALCINSTSET1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041786
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
[10381780125853]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-01-01 |
| Device Publish Date | 2015-09-24 |
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 [CALCANEA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALCANEA 78148646 not registered Dead/Abandoned |
NEWDEAL 2002-07-30 |
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