Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTechfit Digital Surgery, Inc.
US
Last updated May 23, 2026
What Techfit Digital Surgery, Inc. makes
Techfit Digital Surgery, Inc. produces custom-made surgical guides for orthopaedic and craniofacial procedures, as well as tailored anatomical models of organs and bones. Their portfolio also includes cranial bone prostheses designed to fit individual patient anatomy. All products are fabricated to precise specifications for surgical planning and reconstruction.
The company’s devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are manufactured in the United States, adhering to applicable regulatory requirements for custom-made medical devices.
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 Techfit Digital Surgery, Inc. manufacture?
Techfit Digital Surgery, Inc. specializes in custom-made medical devices primarily for surgical applications. Their portfolio includes custom orthopaedic and craniofacial surgical guides, tailored anatomical models of organs and bones, and cranial bone prostheses. These devices are designed to fit individual patient anatomy, supporting precise surgical planning and reconstruction.
Where is Techfit Digital Surgery, Inc. based, and where are their devices manufactured?
Techfit Digital Surgery, Inc. is based in the United States. Their devices are manufactured domestically, adhering to US regulatory standards for custom-made medical devices. This ensures compliance with applicable manufacturing and quality control requirements.
How are Techfit Digital Surgery, Inc.’s devices classified under US regulations?
Techfit Digital Surgery, Inc.’s devices are classified as Class II under US regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as custom-made surgical tools or prostheses.
Are Techfit Digital Surgery, Inc.’s devices listed in any regulatory databases?
Yes, Techfit Digital Surgery, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries help track and identify medical devices that have undergone regulatory review for compliance with US requirements.
Why might a healthcare provider look for Techfit Digital Surgery, Inc.’s devices in regulatory registries?
Healthcare providers may consult regulatory registries like the FDA’s 510(k) and UDI databases to verify that a device has undergone the necessary regulatory processes to ensure safety, performance, and compliance with US standards. For custom-made devices like those from Techfit Digital Surgery, Inc., this helps confirm that the product meets the required controls for its specific classification, such as Class II, before use in surgical procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117050279
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| Techfit | 0 | FDA UDI | Class II | Active |
| TECHFIT DISRP® System | K230276 | FDA 510(k) | Class II | Active |
| TECHFIT DISRP® System | K242263 | FDA 510(k) | Class II | Active |
| TECHFIT Diagnostic Models | K222577 | FDA 510(k) | Class II | Active |
| TECHFIT Patient-Specific Cranial System | K250297 | FDA 510(k) | Class II | Active |
| AFFINITY Proximal Tibia System | K220199 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.