FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
K Number: K254110
·
Decision Mar 18, 2026
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
16
Review Days
89
Basic Information
- Device Name
- DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
- K Number
- K254110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MedShape, Inc.
- Date Received
- December 19, 2025
- Decision Date
- March 18, 2026
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by MedShape, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250628 | DynaNail TTC Fusion System | Sep 12, 2025 | 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 |