AcuTie
GUDID 10814493010753
AcuTie Sternum Plate
ACUTE INNOVATIONS LLC
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 10814493010753 |
| NIH Device Record Key | 8a64cbc7-f9e1-498f-a5fa-a79455c935ff |
| Commercial Distribution Discontinuation | 2021-03-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AcuTie |
| Version Model Number | STW1101 |
| Company DUNS | 619225415 |
| Company Name | ACUTE INNOVATIONS 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 | false |
| 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
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com | |
| Phone | 18666234137 |
| customerservice@acuteinnovations.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10814493010753 [Primary] |
FDA Product Code
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
[10814493010753]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-04-12 |
| Device Publish Date | 2015-09-16 |
Devices Manufactured by ACUTE INNOVATIONS LLC
| 10814493010012 - RibLoc | 2021-04-12 8mm x 46mm Rib Plate |
| 10814493010029 - RibLoc | 2021-04-12 10mm x 46mm Rib Plate |
| 10814493010036 - RibLoc | 2021-04-12 12mm x 46mm Rib Plate |
| 10814493010043 - RibLoc | 2021-04-12 14mm x 46mm Rib Plate |
| 10814493010050 - RibLoc | 2021-04-12 8mm x 61mm Rib Plate |
| 10814493010067 - RibLoc | 2021-04-12 10mm x 61mm Rib Plate |
| 10814493010074 - RibLoc | 2021-04-12 12mm x 61mm Rib Plate |
| 10814493010081 - RibLoc | 2021-04-12 14mm x 61mm Rib Plate |
Trademark Results [AcuTie]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACUTIE 77669341 3688671 Live/Registered |
Acute Innovations, LLC 2009-02-12 |
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