FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
K Number: K061648
·
Decision Sep 11, 2006
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
11
Applicant Total
207
Review Days
90
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Basic Information
- Device Name
- DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
- K Number
- K061648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- June 13, 2006
- Decision Date
- September 11, 2006
- Product Code
- NPJ
- 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 |
|---|---|---|---|
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPJ), ordered by most recent decision date.
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IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
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SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
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RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
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FDA Class 2
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DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
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