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, 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) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (3) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (2) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (JDI) (1)

Premarket Exempt

Clear

B-P TOTAL SHOULDER SYSTEM - 00814193025500 Catalog Number : 02-15-0603

Device Description : B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 7.5 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025517 Catalog Number : 02-15-0604

Device Description : B-P SHOULDER HUMERAL HEAD EXTENSION W/ULTRACOAT - 10 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025524 Catalog Number : 02-21-0103

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

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

B-P TOTAL SHOULDER SYSTEM - 00814193025531 Catalog Number : 02-21-0201

Device Description : B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 1

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 - 00814193025548 Catalog Number : 02-21-0202

Device Description : B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 2

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 - 00814193025555 Catalog Number : 02-21-0203

Device Description : B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 3

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 - 00814193025562 Catalog Number : 02-21-0204

Device Description : B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 4

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWT, HSD, MJT

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193025579 Catalog Number : 03-12-0012

Device Description : B-P KNEE SUBLUXATION CONTROL SCREW W/ULTRACOAT SIZE 1-3

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P TOTAL KNEE SYSTEM - 00814193025586 Catalog Number : 03-12-0036

Device Description : B-P KNEE SUBLUXATION CONTROL SCREW W/ULTRACOAT SIZE 4-6

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

B-P INTERNAL FIXATION ACCESSORIES - 00814193025593 Catalog Number : 03-01-0615

Device Description : B-P BONE SCREW W/ULTRACOAT - 6.5 MM X 15 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

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