FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
K Number: K960425
·
Decision Oct 3, 1996
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
15
Review Days
248
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Basic Information
- Device Name
- BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
- K Number
- K960425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endotec, Inc.
- Date Received
- January 29, 1996
- Decision Date
- October 3, 1996
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K944414 | DEKALB | Sep 27, 1994 | Substantially Equivalent |