FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACETABULAR PLATES
K Number: K002941
·
Decision Dec 4, 2000
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
85
Review Days
74
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACETABULAR PLATES
- K Number
- K002941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Orthopedics, Inc.
- Date Received
- September 21, 2000
- Decision Date
- December 4, 2000
- Product Code
- LWJ
- 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LWJ), ordered by most recent decision date.
UNISYN PLUS HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRINITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
U2 HIP STEM, TI PLASMA SPRAY
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Encore Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT | Jul 6, 2004 | Substantially Equivalent |
| K020114 | 3D KNEE | Jul 12, 2002 | Substantially Equivalent |
| K020741 | UNICONDYLAR KNEE | Jun 4, 2002 | Substantially Equivalent |
| K020236 | MODIFICATION TO PASS SPINAL SYSTEM | Feb 14, 2002 | Substantially Equivalent |
| K020170 | KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP | Feb 11, 2002 | Substantially Equivalent |
| K013490 | CEMENTED CALCAR HIP SYSTEM | Jan 17, 2002 | Substantially Equivalent |
| K013442 | PASS SPINAL SYSTEM | Jan 15, 2002 | Substantially Equivalent |
| K003324 | PLASMA SPRAYED SHOULDER | Dec 6, 2001 | Substantially Equivalent |
| K013431 | PASS SPINAL SYSTEM | Nov 15, 2001 | Substantially Equivalent |
| K013191 | PASS SPINAL SYSTEM | Oct 24, 2001 | Substantially Equivalent |