FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
THOMPSON TYPE HIP PROTHESIS
K Number: K922868
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
18
Review Days
253
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Basic Information
- Device Name
- THOMPSON TYPE HIP PROTHESIS
- K Number
- K922868
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteo Technology, Inc.
- Date Received
- June 4, 1992
- Decision Date
- February 12, 1993
- 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
Other 510(k) clearances with the same product code (KWA), ordered by most recent decision date.
PROFEMUR Z REVISION HIP STEM
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DYNASTY BIOFOAM SHELL
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METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
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CONSERVE THIN SHELL
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FDA Class 3
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PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
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PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
Other Clearances by Osteo Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926156 | REPLICA(TM) TOTAL HIP SYSTEM | Mar 9, 1994 | Substantially Equivalent for Some Indications |
| K922859 | ANATOMICAL TYPE KNEE SYSTEM | Sep 23, 1993 | Substantially Equivalent |
| K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM | Jul 13, 1993 | Substantially Equivalent |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | Jun 29, 1993 | Substantially Equivalent |
| K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM | Jun 17, 1993 | Substantially Equivalent |
| K922861 | BIOMETRIC SCREW FIXATION CUP | May 12, 1993 | Substantially Equivalent |
| K922870 | THREE SPIKE CUP | Apr 8, 1993 | Substantially Equivalent |
| K922682 | AMERICANA HIP PROTHESIS | Mar 16, 1993 | Substantially Equivalent |
| K925301 | OTI ORTHOPEDIC FASTENER SYSTEM | Mar 16, 1993 | Substantially Equivalent |
| K922871 | UNIFIT FEMORAL STEM | Feb 12, 1993 | Substantially Equivalent |