FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
SuperBall-RC
K Number: K244015
·
Decision Feb 19, 2025
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
3
Review Days
55
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Basic Information
- Device Name
- SuperBall-RC
- K Number
- K244015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arcuro Medical , Ltd.
- Date Received
- December 26, 2024
- Decision Date
- February 19, 2025
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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