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 - 00814193020505 Catalog Number : 04-31-1502

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020512 Catalog Number : 04-31-2502

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020529 Catalog Number : 04-31-1503

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020536 Catalog Number : 04-31-2503

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020543 Catalog Number : 04-31-1504

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020550 Catalog Number : 04-31-2504

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020567 Catalog Number : 04-31-1505

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020574 Catalog Number : 04-31-2505

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O BIOCOAT, W/ULTRACOAT, LEFT, 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 - 00814193020581 Catalog Number : 04-31-1506

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020598 Catalog Number : 04-31-2506

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

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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