FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Anchor with Fiber Wire and Disposable Inserter
K Number: K253027
·
Decision May 6, 2026
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
1
Review Days
229
Basic Information
- Device Name
- Anchor with Fiber Wire and Disposable Inserter
- K Number
- K253027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortobio S.A.
- Date Received
- September 19, 2025
- Decision Date
- May 6, 2026
- 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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