FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
K Number: K921525
·
Decision Jan 11, 1995
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
13
Review Days
1013
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Basic Information
- Device Name
- HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
- K Number
- K921525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implant Technology, Inc.
- Date Received
- April 3, 1992
- Decision Date
- January 11, 1995
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Implant Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |