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 - 00814193020307 Catalog Number : 04-31-1204

Device Description : B-P KNEE TRICOMPARTMENTAL 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 - 00814193020314 Catalog Number : 04-31-2204

Device Description : B-P KNEE TRICOMPARTMENTAL 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 - 00814193020321 Catalog Number : 04-31-1205

Device Description : B-P KNEE TRICOMPARTMENTAL 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 - 00814193020338 Catalog Number : 04-31-2205

Device Description : B-P KNEE TRICOMPARTMENTAL 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 - 00814193020345 Catalog Number : 04-31-1206

Device Description : B-P KNEE TRICOMPARTMENTAL 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 - 00814193020352 Catalog Number : 04-31-2206

Device Description : B-P KNEE TRICOMPARTMENTAL 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

B-P TOTAL KNEE SYSTEM - 00814193020369 Catalog Number : 04-31-1301

Device Description : B-P KNEE NARROW 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 - 00814193020376 Catalog Number : 04-31-2301

Device Description : B-P KNEE NARROW 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 - 00814193020383 Catalog Number : 04-31-1302

Device Description : B-P KNEE NARROW 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 - 00814193020390 Catalog Number : 04-31-2302

Device Description : B-P KNEE NARROW 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

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