FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
INTERMEDICS APR(TM) II FEMORAL COMPONENT
K Number: K890450
·
Decision Aug 9, 1989
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
6
Applicant Total
108
Review Days
191
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Basic Information
- Device Name
- INTERMEDICS APR(TM) II FEMORAL COMPONENT
- K Number
- K890450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Intermedics Orthopedics
- Date Received
- January 30, 1989
- Decision Date
- August 9, 1989
- Product Code
- JDJ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDJ), ordered by most recent decision date.
LINK, ACETABULAR REVISION MESH CUP
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OSTEONICS RESTORATION ACETABULAR RING
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EXETER MESH
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FDA Class 2
·General, Plastic Surgery
REFLECTION ACETABULAR REINFORCEMENT RINGS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROTRUSION CAGES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Intermedics Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI | Jul 3, 1997 | Substantially Equivalent |
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | Apr 30, 1997 | Substantially Equivalent |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | Apr 8, 1997 | Substantially Equivalent |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | Feb 27, 1997 | Substantially Equivalent |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | Jan 27, 1997 | Substantially Equivalent |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Jan 16, 1997 | Substantially Equivalent |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | Oct 28, 1996 | Substantially Equivalent |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | Oct 15, 1996 | Substantially Equivalent |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Oct 1, 1996 | Substantially Equivalent |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Sep 3, 1996 | Substantially Equivalent |