FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DynaFuse Fixation System
K Number: K203595
·
Decision Jan 4, 2022
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
6
Review Days
391
Basic Information
- Device Name
- DynaFuse Fixation System
- K Number
- K203595
- 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 9, 2020
- Decision Date
- January 4, 2022
- 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 | ||
|---|---|---|---|
| K240530 | DynaNail Mini Tapered Hybrid | Mar 21, 2024 | Substantially Equivalent |
| K220812 | DynaClip® Bone Staple | Aug 19, 2022 | Substantially Equivalent |
| K193305 | DynaClip Bone Staple | Apr 23, 2020 | Substantially Equivalent |
| K181781 | DynaClipTM Bone Staple | Nov 5, 2018 | Substantially Equivalent |
| K171376 | DynaNail TTC Fusion System | Nov 2, 2017 | Substantially Equivalent |