FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
K Number: K920021
·
Decision Mar 25, 1992
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
13
Review Days
83
Basic Information
- Device Name
- LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
- K Number
- K920021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- IMPLANT TECHNOLOGY, INC.
- Date Received
- January 2, 1992
- Decision Date
- March 25, 1992
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by IMPLANT TECHNOLOGY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K921525 | HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS | Jan 11, 1995 | Substantially Equivalent |
| K915617 | LSF HA COATED FEMORAL HIP | May 28, 1992 | Substantially Equivalent |
| K913616 | LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP | Nov 7, 1991 | Substantially Equivalent |
| K902727 | LSF CEMENTED FEMORAL HIP | Aug 9, 1990 | Substantially Equivalent |
| K901460 | LSF(TM) TOTAL HIP SYSTEM | May 22, 1990 | Substantially Equivalent for Some Indications |
| K891472 | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR | May 2, 1989 | Substantially Equivalent |
| K884432 | MODIFIED LSF TOTAL HIP SYSTEM | Dec 9, 1988 | Substantially Equivalent |
| K883212 | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | Nov 22, 1988 | Substantially Equivalent |
| K855017 | LSF* TOTAL HIP SYSTEM | Jun 11, 1986 | Substantially Equivalent for Some Indications |
| K841546 | COMMUNI-TRACH TUBE | Apr 30, 1984 | Substantially Equivalent |