FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
OTS 25-L (100-5)
K Number: K241234
·
Decision Jan 23, 2025
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
3
Review Days
266
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Basic Information
- Device Name
- OTS 25-L (100-5)
- K Number
- K241234
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ots Medical , Ltd.
- Date Received
- May 2, 2024
- Decision Date
- January 23, 2025
- 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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