FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
SINEFIX
K Number: K220966
·
Decision Mar 8, 2023
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
5
Review Days
341
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Basic Information
- Device Name
- SINEFIX
- K Number
- K220966
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAAT Medical Products B.V.
- Date Received
- April 1, 2022
- Decision Date
- March 8, 2023
- 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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