FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioBrace ® RC Delivery System
K Number: K250395
·
Decision Apr 7, 2025
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
82
Review Days
54
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Basic Information
- Device Name
- BioBrace ® RC Delivery System
- K Number
- K250395
- 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
- Conmed Corporation
- Date Received
- February 12, 2025
- Decision Date
- April 7, 2025
- Product Code
- ORQ
- 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 |
|---|---|---|---|
| ORQ | Mesh, Surgical, Deployer | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ORQ), ordered by most recent decision date.
ACCUMESH DEPLOYMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCUMESH DEPLOYMENT SYSTEM
FDA 510(k)
FDA Class 2
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ACCUMESH DEPLOYMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATCHASSIST LARGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATCHASSIST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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