| Primary Device ID | 10855068008751 |
| NIH Device Record Key | 7efaa8f7-2ea3-4b7d-a829-48415a26b6a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Removal Drill, 13.0 mm |
| Version Model Number | RKD-002 |
| Catalog Number | RKD-002 |
| Company DUNS | 039779098 |
| Company Name | Curvafix Inc |
| 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 | 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 |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com | |
| Phone | 425-276-8800 |
| support@curvafix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10855068008751 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
[10855068008751]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-04 |
| Device Publish Date | 2023-09-26 |
| 10855068008126 - Drill Wire Kit | 2024-12-13 A single use kit, composed of a sterile packaged Drill Wire and Exchange Tube, that is used during a surgical procedure for the |
| 10855068008744 - Removal Drill, 9.5mm | 2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover |
| 10855068008751 - Removal Drill, 13.0 mm | 2023-10-04A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or covering the proximal head of a CurvaFix Implant. |
| 10855068008751 - Removal Drill, 13.0 mm | 2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover |
| 10855068008768 - Tissue Sleeve, Removal Tool | 2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protec |
| 10855068008782 - Pin Sleeve, Removal Tool | 2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal that fits inside the Tissue Sleeve and contains a conica |
| 10855068008829 - Removal Tool Set | 2023-10-04 A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used to remove a |
| 10855068008836 - Sterilization Case, Removal Tool Set | 2023-10-04 A reusable instrument storage case that can house and retain the reusable instruments of the Removal Tool Set during sterilizati |
| 10855068008843 - Removal Coring Tool, Proximal Head | 2023-10-04 A T-handled cutting instrument with a cannula used over a wire to manually remove bone in a cylindral shape around the proximal |