ENDOTEC, INC.

Address:1501 N. Harbor blvd.,Fullerton,CA,92835,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (10)

Premarket Exempt

Clear

B-P TOTAL KNEE SYSTEM - 00814193020000 Catalog Number : 04-31-1001

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, RIGHT, SIZE 1

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020017 Catalog Number : 04-31-2001

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, LEFT, SIZE 1

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020024 Catalog Number : 04-31-1002

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT RIGHT, SIZE 2

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020031 Catalog Number : 04-31-2002

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, LEFT, SIZE 2

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020048 Catalog Number : 04-31-1003

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, RIGHT, SIZE 3

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020055 Catalog Number : 04-31-2003

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, LEFT, SIZE 3

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020062 Catalog Number : 04-31-1004

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, RIGHT, SIZE 4

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020079 Catalog Number : 04-31-2004

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, LEFT, SIZE 4

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020086 Catalog Number : 04-31-1005

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, RIGHT, SIZE 5

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020093 Catalog Number : 04-31-2005

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, LEFT, SIZE 5

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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