Total clearances
5
2022-03-21 → 2025-10-27
Name variants in FDA filings: Techfit Digital Surgery / Techfit Digital Surgery, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| DZJ |
Driver, Wire, And Bone Drill, Manual |
Class II |
Dental |
2 |
2024-12-11 |
| GWO |
Plate, Cranioplasty, Preformed, Alterable |
Class II |
Neurology |
1 |
2025-10-27 |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
1 |
2023-01-06 |
| HRS |
Plate, Fixation, Bone |
Class II |
Orthopedic |
1 |
2022-03-21 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-10-27 |
K250297 |
TECHFIT Patient-Specific Cranial System |
GWO |
Class II |
Neurology |
| 2024-12-11 |
K242263 |
TECHFIT DISRP® System |
DZJ |
Class II |
Dental |
| 2023-06-23 |
K230276 |
TECHFIT DISRP® System |
DZJ |
Class II |
Dental |
| 2023-01-06 |
K222577 |
TECHFIT Diagnostic Models |
LLZ |
Class II |
Radiology |
| 2022-03-21 |
K220199 |
AFFINITY Proximal Tibia System |
HRS |
Class II |
Orthopedic |