FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K Number: K003523
·
Decision Dec 13, 2000
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
207
Review Days
28
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Basic Information
- Device Name
- DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K Number
- K003523
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- November 15, 2000
- Decision Date
- December 13, 2000
- Product Code
- KWA
- 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 |
|---|---|---|---|
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWA), ordered by most recent decision date.
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PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
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| K210167 | DELTA XTEND Reverse Shoulder System | Feb 19, 2021 | Substantially Equivalent |
| K203167 | DePuy Corail AMT Hip Prosthesis | Nov 19, 2020 | Substantially Equivalent |
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| K201347 | DePuy ATTUNE Total Knee System | Jun 18, 2020 | Substantially Equivalent |
| K193540 | TRUMATCH Personalized Solutions | Jun 16, 2020 | Substantially Equivalent |
| K193398 | Summit DuoFix HA Coating | Feb 4, 2020 | Substantially Equivalent |
| K192946 | DePuy Corail AMT Hip Prosthesis | Nov 26, 2019 | Substantially Equivalent |