FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K Number: K051879
·
Decision Oct 5, 2005
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
402
Review Days
86
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Basic Information
- Device Name
- SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
- K Number
- K051879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- July 11, 2005
- Decision Date
- October 5, 2005
- Product Code
- FTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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