FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Extremity All Suture System
K Number: K241695
·
Decision Sep 12, 2024
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
564
Applicant Total
1
Review Days
92
Basic Information
- Device Name
- Extremity All Suture System
- K Number
- K241695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Field Orthopaedics
- Date Received
- June 12, 2024
- Decision Date
- September 12, 2024
- 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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