FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPUY SPA POROUS COATED PROXIMAL SLEEVE
K Number: K071059
·
Decision Nov 9, 2007
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
32
Applicant Total
194
Review Days
207
Basic Information
- Device Name
- DEPUY SPA POROUS COATED PROXIMAL SLEEVE
- K Number
- K071059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3310
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEPUY ORTHOPAEDICS, INC.
- Date Received
- April 16, 2007
- Decision Date
- November 9, 2007
- Product Code
- KWZ
- 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 |
|---|---|---|---|
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | FDA class 2 | Orthopedic |
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|---|---|---|---|
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