FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RedPoint Medical's Better Bunion System
K Number: K220717
·
Decision Jun 9, 2022
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
26
Applicant Total
1
Review Days
90
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Basic Information
- Device Name
- RedPoint Medical's Better Bunion System
- K Number
- K220717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Redpoint Medical, LLC
- Date Received
- March 11, 2022
- Decision Date
- June 9, 2022
- Product Code
- PBF
- 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 |
|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | FDA class 2 | Orthopedic |
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