FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TekBrace Solo Soft Tissue Reinforcement Device
K Number: K251063
·
Decision May 30, 2025
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
3
Applicant Total
3
Review Days
56
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Basic Information
- Device Name
- TekBrace Solo Soft Tissue Reinforcement Device
- K Number
- K251063
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theramicro
- Date Received
- April 4, 2025
- Decision Date
- May 30, 2025
- Product Code
- QUW
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QUW), ordered by most recent decision date.
TekBrace Solo Soft Tissue Reinforcement Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Jewel Soft Tissue Reinforcement Device (102-6005)
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FDA Class 2
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Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery