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) (10)

Premarket Exempt

Clear

B-P TOTAL SHOULDER SYSTEM - 00814193025104 Catalog Number : 02-02-2252

Device Description : B-P SHOULDER GLENOID BEARING SIZE 2, 2.5 MM THICKNESS, 52 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 - 00814193025111 Catalog Number : 02-02-2344

Device Description : B-P SHOULDER GLENOID BEARING SIZE 3, 2.5 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 - 00814193025128 Catalog Number : 02-02-2348

Device Description : B-P SHOULDER GLENOID BEARING SIZE 3, 2.5 MM THICKNESS, 48 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 - 00814193025135 Catalog Number : 02-02-2352

Device Description : B-P SHOULDER GLENOID BEARING SIZE 3, 2.5 MM THICKNESS, 52 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 - 00814193025142 Catalog Number : 02-02-2444

Device Description : B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 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 - 00814193025159 Catalog Number : 02-02-2448

Device Description : B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 48 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 - 00814193025166 Catalog Number : 02-02-2452

Device Description : B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 52 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 - 00814193025173 Catalog Number : 02-02-2456

Device Description : B-P SHOULDER GLENOID BEARING SIZE 4, 2.5 MM THICKNESS, 56 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 - 00814193025180 Catalog Number : 02-02-5244

Device Description : B-P SHOULDER GLENOID BEARING SIZE 2, 5 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 - 00814193025197 Catalog Number : 02-02-5248

Device Description : B-P SHOULDER GLENOID BEARING SIZE 2, 5 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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