FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BowTie SI Joint Fusion System
K Number: K232149
·
Decision Apr 20, 2024
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
1
Review Days
276
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Basic Information
- Device Name
- BowTie SI Joint Fusion System
- K Number
- K232149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sail Fusion, LLC
- Date Received
- July 19, 2023
- Decision Date
- April 20, 2024
- Product Code
- OUR
- 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 |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
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