FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DynaNail TTC Fusion System
K Number: K250628
·
Decision Sep 12, 2025
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
16
Review Days
193
Basic Information
- Device Name
- DynaNail TTC Fusion System
- K Number
- K250628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MedShape, Inc.
- Date Received
- March 3, 2025
- Decision Date
- September 12, 2025
- Product Code
- HSB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k)
FDA Class 2
·Orthopedic
Precice Max System and Precice Ankle Salvage System
FDA 510(k)
FDA Class 2
·Orthopedic
Fule Metallic Lockable Intramedullary Nail Systems
FDA 510(k)
FDA Class 2
·Orthopedic
HERA Interlocking Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by MedShape, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | Mar 18, 2026 | Substantially Equivalent |
| K240530 | DynaNail Mini Tapered Hybrid | Mar 21, 2024 | Substantially Equivalent |
| K220812 | DynaClip® Bone Staple | Aug 19, 2022 | Substantially Equivalent |
| K203595 | DynaFuse Fixation System | Jan 4, 2022 | Substantially Equivalent |
| K203381 | Dynanail Mini Hybrid | Jan 15, 2021 | Substantially Equivalent |
| K193305 | DynaClip Bone Staple | Apr 23, 2020 | Substantially Equivalent |
| K182677 | DynaNail Mini | Feb 14, 2019 | Substantially Equivalent |
| K181781 | DynaClipTM Bone Staple | Nov 5, 2018 | Substantially Equivalent |
| K171376 | DynaNail TTC Fusion System | Nov 2, 2017 | Substantially Equivalent |
| K141420 | FASTFORWARD | Dec 18, 2014 | Substantially Equivalent |