FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
K Number: K883212
·
Decision Nov 22, 1988
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
22
Applicant Total
13
Review Days
116
Basic Information
- Device Name
- LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
- K Number
- K883212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3400
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- IMPLANT TECHNOLOGY, INC.
- Date Received
- July 29, 1988
- Decision Date
- November 22, 1988
- Product Code
- KXA
- 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 |
|---|---|---|---|
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 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 |
| K920021 | LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP | Mar 25, 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 |
| K855017 | LSF* TOTAL HIP SYSTEM | Jun 11, 1986 | Substantially Equivalent for Some Indications |
| K841546 | COMMUNI-TRACH TUBE | Apr 30, 1984 | Substantially Equivalent |