FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
BUECHEL-PAPPAS MODULAR SALVAGE STEM
K Number: K982418
·
Decision Apr 29, 1999
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
2
Applicant Total
15
Review Days
290
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Basic Information
- Device Name
- BUECHEL-PAPPAS MODULAR SALVAGE STEM
- K Number
- K982418
- Device Class
- FDA class 3
- Clearance Type
- Abbreviated
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endotec, Inc.
- Date Received
- July 13, 1998
- Decision Date
- April 29, 1999
- Product Code
- MJT
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MJT), ordered by most recent decision date.
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
FDA 510(k)
FDA Class 3
·Unknown
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143
FDA 510(k)
FDA Class 3
·Unknown
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 |
| 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 |
| K944414 | DEKALB | Sep 27, 1994 | Substantially Equivalent |