FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K Number: K843940
·
Decision Jun 3, 1985
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
113
Applicant Total
12
Review Days
237
Basic Information
- Device Name
- LINK CEMENTLESS SCREW-IN ACETABULAR CUP
- K Number
- K843940
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- WALDEMAR LINK GMBH & CO. KG
- Date Received
- October 9, 1984
- Decision Date
- June 3, 1985
- 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
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Other Clearances by WALDEMAR LINK GMBH & CO. KG
| K Number | Device Name | ||
|---|---|---|---|
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating | May 9, 2016 | Substantially Equivalent |
| K142187 | LINK MP RECONSTRUCTION PROSTHESIS | Nov 6, 2014 | Substantially Equivalent |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Nov 18, 2005 | Substantially Equivalent |
| K852705 | LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS | Aug 13, 1985 | Substantially Equivalent |
| K843950 | LINK CEMENTLESS SCREW-IN ACETABULAR CUP | Jun 3, 1985 | Substantially Equivalent |
| K844225 | LINK ACETABULAR MESH | Nov 14, 1984 | Substantially Equivalent |
| K800800 | PATELLAR COMPONENT FOR LUBINUS PATELLAR | Apr 21, 1980 | Substantially Equivalent |
| K792200 | TILLMAN HIP RESURFACING REPLACEMT PROS. | Dec 5, 1979 | Substantially Equivalent |
| K790488 | INTERPLANTA SP TOTAL HIP PROSTHESIS | Mar 28, 1979 | Substantially Equivalent |
| K781735 | ENDOPROSTHESIS SYSTEM, VARIO-HEAD | Oct 24, 1978 | Substantially Equivalent |