FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Fixone Biocomposite Anchor
K Number: K171299
·
Decision Aug 24, 2017
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
213
Applicant Total
3
Review Days
113
Basic Information
- Device Name
- Fixone Biocomposite Anchor
- K Number
- K171299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AJU Pharm Co.,Ltd.
- Date Received
- May 3, 2017
- Decision Date
- August 24, 2017
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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