FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR
K Number: K063273
·
Decision Nov 22, 2006
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
1
Review Days
23
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Basic Information
- Device Name
- PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR
- K Number
- K063273
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Miltek, A Johnson & Johnson Co.
- Date Received
- October 30, 2006
- Decision Date
- November 22, 2006
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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