FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Y WIRE 2
K Number: K140576
·
Decision May 20, 2014
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
2
Applicant Total
1
Review Days
75
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Basic Information
- Device Name
- Y WIRE 2
- K Number
- K140576
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Safewire, LLC
- Date Received
- March 6, 2014
- Decision Date
- May 20, 2014
- Product Code
- HXI
- 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 |
|---|---|---|---|
| HXI | Passer, Wire, Orthopedic | FDA class 1 | Orthopedic |
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