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, Hip, Semi-Constrained, Metal/Polymer, Cemented (JDI) (4) Prosthesis, Hip, Hemi-, Femoral, Metal (KWL) (1)

Premarket Exempt

Clear

B-P INTERNAL FIXATION ACCESSORIES - 00814193025609 Catalog Number : 03-01-0620

Device Description : B-P BONE SCREW W/ULTRACOAT - 6.5 MM X 20 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

B-P INTERNAL FIXATION ACCESSORIES - 00814193025616 Catalog Number : 03-01-0625

Device Description : B-P BONE SCREW W/ULTRACOAT - 6.5 MM X 25 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

B-P INTERNAL FIXATION ACCESSORIES - 00814193025623 Catalog Number : 03-01-0640

Device Description : B-P BONE SCREW W/ULTRACOAT - 6.5 MM X 40 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

B-P INTERNAL FIXATION ACCESSORIES - 00814193025630 Catalog Number : 03-01-0650

Device Description : B-P BONE SCREW W/ULTRACOAT - 6.5 MM X 50 MM

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

B-P INTERNAL FIXATION ACCESSORIES - 00814193025647 Catalog Number : 03-04-0011

Device Description : B-P MODULAR EXTENSION SCREW W/O ULTRACOAT

Device Class : 2

Duns Number: 803488357

Premarket Exempt : No

Product Code : KWL

Prescription Use : Yes

Device Count : 1

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