FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
K Number: K904870
·
Decision May 23, 1991
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
22
Applicant Total
15
Review Days
212
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Basic Information
- Device Name
- MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
- K Number
- K904870
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3400
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Endotec, Inc.
- Date Received
- October 23, 1990
- Decision Date
- May 23, 1991
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXA), ordered by most recent decision date.
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CORMET CEMENTLESS RESURFACING FEMORAL HEAD
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CONSERVE PRESSFIT FEMORAL COMPONENT
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RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
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DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
CONSERVE FEMORAL RESURFACING COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Endotec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081400 | FANNING-PAPPAS MODULAR KNEE BEARING | Feb 20, 2009 | Substantially Equivalent |
| K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 | Jan 30, 2002 | Substantially Equivalent |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | Oct 15, 1999 | Substantially Equivalent |
| K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM | Apr 29, 1999 | Substantially Equivalent |
| K963101 | B-P HEMISPHERICAL ACETABULAR COMPONENT | Feb 12, 1997 | Substantially Equivalent |
| K963100 | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP | Feb 12, 1997 | Substantially Equivalent |
| K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX | Oct 3, 1996 | Substantially Equivalent |
| K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD | Aug 26, 1996 | Substantially Equivalent |
| K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES | Jun 6, 1995 | Substantially Equivalent |
| K944465 | CARRIER, LIGATURE (79 GEJ) | Sep 28, 1994 | Substantially Equivalent |