| Primary Device ID | 10855068008768 |
| NIH Device Record Key | 740067ab-d47b-4a38-8ed2-7e7457d5380e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tissue Sleeve, Removal Tool |
| Version Model Number | RKS-001 |
| Catalog Number | RKS-001 |
| 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 | 10855068008768 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
Moist Heat or Steam Sterilization
[10855068008768]
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 | 2023-10-04 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 | 2023-10-04A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protect the patient soft tissue. It also contains three integrated holes around the outside diameter to accept Guide Pins to maintain the sleeve position hands-free. |
| 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 |