FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrex BioSync® Bone Wedge
K Number: K151256
·
Decision Aug 12, 2015
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
17
Applicant Total
3
Review Days
92
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Basic Information
- Device Name
- Arthrex BioSync® Bone Wedge
- K Number
- K151256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthex, Inc.
- Date Received
- May 12, 2015
- Decision Date
- August 12, 2015
- Product Code
- PLF
- 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 |
|---|---|---|---|
| PLF | Bone Wedge | FDA class 2 | Orthopedic |
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