FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
K Number: K132636
·
Decision Oct 17, 2013
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
423
Review Days
56
Basic Information
- Device Name
- DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
- K Number
- K132636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SMITH & NEPHEW, INC.
- Date Received
- August 22, 2013
- Decision Date
- October 17, 2013
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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