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Sign in to claim this brandCurvafix Inc
US
Last updated May 24, 2026
What Curvafix Inc makes
Curvafix Inc manufactures reusable orthopaedic surgical instruments and implants, including non-bioabsorbable bone screws, intramedullary nails for arthrodesis, and guidewires for spinal and long-bone procedures. Their portfolio also includes reusable components like surgical drill bits, implant inserters/extractors, sterilization containers, and procedure kits designed for spinal and joint surgeries. Specific products include intramedullary implants, instrument sets, cannulated tools, and protective sleeves for surgical hardware.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories, requiring premarket submissions such as 510(k)s and Unique Device Identifiers (UDIs). These products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device authorization requirements. Curvafix Inc operates from the United States, adhering to domestic regulatory standards for surgical instruments and implants.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Curvafix Inc manufacture?
Curvafix Inc specializes in reusable orthopaedic surgical instruments and implants. Their portfolio includes non-bioabsorbable bone screws, arthrodesis intramedullary nails (non-distracting), guidewires, and reusable components like surgical drill bits, implant inserters/extractors, sterilization containers, and procedure kits. These devices are designed for spinal and joint surgeries, ensuring compatibility with orthopaedic procedures requiring precision hardware.
Where is Curvafix Inc based, and how does this affect its regulatory compliance?
Curvafix Inc is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class I and Class II classifications, they must comply with U.S. requirements for premarket submissions, such as 510(k) clearances and Unique Device Identifier (UDI) assignments. This ensures their devices meet U.S. safety and performance standards before authorization.
Which regulatory registries or databases list Curvafix Inc’s devices?
Curvafix Inc’s devices are listed in the FDA’s regulatory databases, specifically the 510(k) and Unique Device Identifier (UDI) registries. These listings confirm that the company’s products have undergone the necessary premarket evaluations to comply with U.S. medical device authorization requirements, including classification under Class I or Class II. This transparency helps healthcare providers verify regulatory compliance.
How are Curvafix Inc’s devices classified under FDA regulations?
Curvafix Inc’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls like performance standards or post-market surveillance. The classification determines the regulatory pathway, such as 510(k) submissions for Class II, ensuring these products meet safety and effectiveness standards before use.
What distinguishes Curvafix Inc’s reusable orthopaedic instruments from single-use alternatives?
Curvafix Inc’s reusable orthopaedic instruments, such as drill bits, inserters, and sterilization containers, are designed for repeated use with proper cleaning and sterilization. Unlike single-use alternatives, these instruments reduce waste and operational costs while maintaining precision for procedures like spinal fusion or joint replacements. Their reusable components—like guidewires and implant inserters—are engineered for durability and compatibility with non-bioabsorbable implants, ensuring long-term reliability in surgical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- curvafix.com
- —
- —
- [email protected]
- Phone
- 425-276-8800
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 039779098
Catalogue (87)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Implant Selection Device | ISD-002 | FDA UDI | Class I | Active |
| CurvaFix® IM Implant | 7.5 mm x 130 mm | FDA UDI | Class II | Active |
| Bead Extractor, 8.0 mm | RKG-001 | FDA UDI | Class I | Active |
| Inserter/Extractor | CIA-001 | FDA UDI | Class II | Active |
| Step Drill | CSD-001 | FDA UDI | Class I | Active |
| CurvaFix® IM Implant | 7.5 mm x 170 mm | FDA UDI | Class II | Active |
| Cannulated Hammer | CCH-001 | FDA UDI | Class I | Active |
| Lock Activator | CLA-001 | FDA UDI | Class II | Active |
| CurvaFix® IM Implant | 7.5 mm x 180 mm | FDA UDI | Class II | Active |
| Core Wire, Removal Tool | CRT-002 | FDA UDI | Class I | Active |
| Countersink | CCB-002 | FDA UDI | Class I | Active |
| CurvaFix® IM Implant | 7.5 mm x 120 mm | FDA UDI | Class II | Active |
| Cannulated Step Drill, Small Implant | CSD-002 | FDA UDI | Class I | Active |
| CurvaFix® IM Implant | 9.5 MM x 150 MM, Self Tapping | FDA UDI | Class II | Active |
| CurvaFix® IM Implant | 9.5 MM x 180 MM, Self Tapping | FDA UDI | Class II | Active |
| Torque Limiting Handle | CTH-002 | FDA UDI | Class I | Active |
| CurvaFix® IM Implant | 7.5 mm x 100 mm | FDA UDI | Class II | Active |
| Removal Coring Tool, Distal Bead | RKC-002 | FDA UDI | Class I | Active |
| Sterilization Tray, Lower | CIT-002 | FDA UDI | Class II | Active |
| CurvaFix® IM Implant | 9.5 MM x 200 MM, Self Tapping | FDA UDI | Class II | Active |
| 9.0MM Flexible Reamer | CFR-090 | FDA UDI | Class I | Active |
| Inserter/Extractor | CIA-002 | FDA UDI | Class II | Active |
| Guide Pin, 2.8mm Smooth | GPS-001 | FDA UDI | Class I | Active |
| Removal Tool | CRT-001 | FDA UDI | Class I | Active |
| 6.5MM Flexible Reamer | CFR-065 | FDA UDI | Class I | Active |
| Implant Selection Device Set | CIS-002 | FDA UDI | Class II | Active |
| Quick Disconnect | PQD-001 | FDA UDI | Class I | Active |
| Lock Activator | CSA-001 | FDA UDI | Class II | Active |
| CurvaFix® IM Implant | 9.5 MM x 210 MM, Self Tapping | FDA UDI | Class II | Active |
| Steerable Guide Sleeve | CGS-002 | FDA UDI | Class I | Active |
| Cannulated Alignment Tube | CAT-001 | FDA UDI | Class I | Active |
| CurvaFix® IM Implant | 7.5 mm x 150 mm | FDA UDI | Class II | Active |
| Instrument Sterilization Case | CIC-001 | FDA UDI | Class II | Active |
| Removal Drill, 9.5mm | RKD-001 | FDA UDI | Class I | Active |
| CurvaFix IM System | K222505 | FDA 510(k) | Class II | Active |
| CurvaFix Intramedullary Rodscrew System | K180050 | FDA 510(k) | Class II | Active |
| CurvaFix Low Profile System | K252019 | FDA 510(k) | Class II | Active |
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