Search Results
Found 8 results
510(k) Data Aggregation
K Number
K081400Device Name
FANNING-PAPPAS MODULAR KNEE BEARING
Manufacturer
ENDOTEC, INC.
Date Cleared
2009-02-20
(277 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis, in knees having coirectable mity, and viable or reconstructable ligaments. valgus or var ..
Device Description
Not Found
Ask a Question
K Number
K012702Device Name
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
Manufacturer
ENDOTEC, INC.
Date Cleared
2002-01-30
(169 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BUECHEL-PAPPAS (B-P) Fixed Bearing New Jersey (NJ) Total Knee Replacement System is intended for the reconstruction of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Additionally, it is intended for Subjects with severe arthritis (e.g. Posttraumatic, rheumatoid or osteoarthritis.). with sufficient bone stock (i.e. cortical bone present to support the platform of the components) and ligamentous support (i.e. intact medial and lateral collateral ligaments) to allow stable, anatomical positioning of components and supporting tissue structures, who are skellatly mature and have not responded to conservative treatment (i.e. injections, therapy, etc.). Porous components and textured components are intended for cemented use.
Device Description
Buechel-Pappas (B-P) Fixed Bearing New Jersey Total Knee Replacement System
Ask a Question
K Number
K992394Device Name
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
Manufacturer
ENDOTEC, INC.
Date Cleared
1999-10-15
(88 days)
Product Code
HSD
Regulation Number
888.3690Why did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.
Device Description
Not Found
Ask a Question
K Number
K982418Device Name
BUECHEL-PAPPAS MODULAR SALVAGE STEM
Manufacturer
ENDOTEC, INC.
Date Cleared
1999-04-29
(290 days)
Product Code
MJT, HSD, KWT
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis, rheumatiod arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis; for use in the absence of a functionally sufficient rotator cuff as well as where the proximal humerus is insufficient to support a standard angled humeral prosthesis. Biocoat® porous coated components are intended for cemented use.
Device Description
Not Found
Ask a Question
K Number
K963100Device Name
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
Manufacturer
ENDOTEC, INC.
Date Cleared
1997-02-12
(187 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K963101Device Name
B-P HEMISPHERICAL ACETABULAR COMPONENT
Manufacturer
ENDOTEC, INC.
Date Cleared
1997-02-12
(187 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K960425Device Name
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
Manufacturer
ENDOTEC, INC.
Date Cleared
1996-10-03
(248 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K960424Device Name
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
Manufacturer
ENDOTEC, INC.
Date Cleared
1996-08-26
(210 days)
Product Code
KWT
Regulation Number
888.3650Why did this record match?
Applicant Name (Manufacturer) :
ENDOTEC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1