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, Shoulder, Hemi-, Humeral, Metallic Uncemented (HSD) (4) Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented (MJT) (4) Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (4)

Premarket Exempt

Clear

B-P TOTAL SHOULDER SYSTEM - 00814193025401 Catalog Number : 02-04-0214

Device Description : B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 14 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025418 Catalog Number : 02-04-0344

Device Description : B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 44 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025425 Catalog Number : 02-04-0348

Device Description : B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 48 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025432 Catalog Number : 02-04-0352

Device Description : B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 52 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025449 Catalog Number : 02-04-0608

Device Description : B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 8 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWT, HSD, MJT

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025456 Catalog Number : 02-04-0610

Device Description : B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 10 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWT, HSD, MJT

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025463 Catalog Number : 02-04-0612

Device Description : B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 12 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWT, HSD, MJT

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025470 Catalog Number : 02-04-0614

Device Description : B-P SHOULDER SALVAGE HUMERAL STEM W/ BIOCOAT & W/ULTRACOAT - 14 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWT, HSD, MJT

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025487 Catalog Number : 02-15-0601

Device Description : B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 2.5 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025494 Catalog Number : 02-15-0602

Device Description : B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 5 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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