FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHFIT Patient-Specific Cranial System
K Number: K250297
·
Decision Oct 27, 2025
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
4
Review Days
269
Basic Information
- Device Name
- TECHFIT Patient-Specific Cranial System
- K Number
- K250297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techfit Digital Surgery, Inc.
- Date Received
- January 31, 2025
- Decision Date
- October 27, 2025
- Product Code
- GWO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWO), ordered by most recent decision date.
Fusion Craniofacial Implant; Fusion Skull Implant
FDA 510(k)
FDA Class 2
·Neurology
VSP PEEK Cranial Implant
FDA 510(k)
FDA Class 2
·Neurology
MCI-Neuro Fixation System
FDA 510(k)
FDA Class 2
·Neurology
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
FDA 510(k)
FDA Class 2
·Neurology
Stryker PEEK Customized Cranial Implant Kit
FDA 510(k)
FDA Class 2
·Neurology
Optimus NEURO System - Sterile Kit
FDA 510(k)
FDA Class 2
·Neurology