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 - 00814193020406 Catalog Number : 04-31-1303

Device Description : B-P KNEE NARROW 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 - 00814193020413 Catalog Number : 04-31-2303

Device Description : B-P KNEE NARROW 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 - 00814193020420 Catalog Number : 04-31-1304

Device Description : B-P KNEE NARROW 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 - 00814193020437 Catalog Number : 04-31-2304

Device Description : B-P KNEE NARROW 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 - 00814193020444 Catalog Number : 04-31-1305

Device Description : B-P KNEE NARROW 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 - 00814193020451 Catalog Number : 04-31-2305

Device Description : B-P KNEE NARROW 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

B-P TOTAL KNEE SYSTEM - 00814193020468 Catalog Number : 04-31-1306

Device Description : B-P KNEE NARROW 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 - 00814193020475 Catalog Number : 04-31-2306

Device Description : B-P KNEE NARROW 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 - 00814193020482 Catalog Number : 04-31-1501

Device Description : B-P KNEE NARROW FEMORAL COMPONENT, W/O 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 - 00814193020499 Catalog Number : 04-31-2501

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

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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