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, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (6) Prosthesis, Hip, Hemi-, Femoral, Metal Ball (LZY) (4)

Premarket Exempt

Clear

B-P TOTAL HIP SYSTEM - 00814193024909 Catalog Number : 01-34-1528

Device Description : B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 15 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : LZY

Prescription Use : Yes

Device Count : 1

B-P TOTAL HIP SYSTEM - 00814193024916 Catalog Number : 01-34-1532

Device Description : B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 15 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : LZY

Prescription Use : Yes

Device Count : 1

B-P TOTAL HIP SYSTEM - 00814193024923 Catalog Number : 01-34-2028

Device Description : B-P HIP FEMORAL HEAD CO-CR-MO - 28 MM + 20 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : LZY

Prescription Use : Yes

Device Count : 1

B-P TOTAL HIP SYSTEM - 00814193024930 Catalog Number : 01-34-2032

Device Description : B-P HIP FEMORAL HEAD CO-CR-MO - 32 MM + 20 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : LZY

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193024947 Catalog Number : 02-01-0001

Device Description : B-P SHOULDER GLENOID FIXATION CUP W/BIOCOAT & W/ULTRACOAT - SIZE 1

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193024954 Catalog Number : 02-01-0002

Device Description : B-P SHOULDER GLENOID FIXATION CUP W/BIOCOAT & W/ULTRACOAT - SIZE 2

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193024961 Catalog Number : 02-01-0003

Device Description : B-P SHOULDER GLENOID FIXATION CUP W/BIOCOAT & W/ULTRACOAT - SIZE 3

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193024978 Catalog Number : 02-01-0004

Device Description : B-P SHOULDER GLENOID FIXATION CUP W/BIOCOAT & W/ULTRACOAT - SIZE 4

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193024985 Catalog Number : 02-02-0244

Device Description : B-P SHOULDER GLENOID BEARING SIZE 2, 0 MM THICKNESS, 44 MM HUMERAL HEAD

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193024992 Catalog Number : 02-02-0248

Device Description : B-P SHOULDER GLENOID BEARING SIZE 2, 0 MM THICKNESS, 48 MM HUMERAL HEAD

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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