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 - 00814193020109 Catalog Number : 04-31-1006

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, RIGHT, SIZE 6

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020116 Catalog Number : 04-31-2006

Device Description : B-P KNEE TRICOMPARTMENTAL FEMORAL COMPONENT, W/BIOCOAT, W/ULTRACOAT, LEFT, SIZE 6

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193020123 Catalog Number : 04-31-1101

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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 - 00814193020130 Catalog Number : 04-31-2101

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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 - 00814193020147 Catalog Number : 04-31-1102

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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 - 00814193020154 Catalog Number : 04-31-2102

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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 - 00814193020161 Catalog Number : 04-31-1103

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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 - 00814193020178 Catalog Number : 04-31-2103

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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 - 00814193020185 Catalog Number : 04-31-1104

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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 - 00814193020192 Catalog Number : 04-31-2104

Device Description : B-P KNEE MODULAR FEMORAL COMPONENT W/SCREW, 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

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