Encore Medical, L.P.

Address:9800 METRIC BLVD.,AUSTIN,TX,78758,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

Chisel, Bone, Surgical (EML) (3) TEMPLATE (HWT) (3) PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED (JDC) (2) Orthopedic manual surgical instrument (LXH) (1) TRAY, SURGICAL, INSTRUMENT (FSM) (1)

Premarket Exempt

No Yes

Clear

DJO SURGICAL - 00190446135760 Catalog Number :

Device Description : AltiVate Reverse, Humeral Shell Trial Guide Pin

Device Class : 1

Duns Number: 154074504

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

DJO SURGICAL - 00190446135777 Catalog Number :

Device Description : RSP X-ray Template

Device Class : 1

Duns Number: 154074504

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

DJO SURGICAL - 00190446135784 Catalog Number :

Device Description : AltiVate Reverse X-ray Template

Device Class : 1

Duns Number: 154074504

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

DJO SURGICAL - 00190446135791 Catalog Number :

Device Description : AltiVate Reverse Revision Instruments Tray

Device Class : 1

Duns Number: 154074504

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

DJO SURGICAL - 00190446136569 Catalog Number :

Device Description : Empowr Box Cut Guide Chisel, SZ 6 and 7

Device Class : 1

Duns Number: 154074504

Premarket Exempt : No

Product Code : EML

Prescription Use : No

Device Count : 1

DJO SURGICAL - 00190446136576 Catalog Number :

Device Description : Empowr Box Cut Guide Chisel, SZ 8 and 9

Device Class : 1

Duns Number: 154074504

Premarket Exempt : No

Product Code : EML

Prescription Use : No

Device Count : 1

DJO SURGICAL - 00190446136583 Catalog Number :

Device Description : Empowr Box Cut Guide Chisel, SZ 10 and 11

Device Class : 1

Duns Number: 154074504

Premarket Exempt : No

Product Code : EML

Prescription Use : No

Device Count : 1

DJO SURGICAL - 00190446136590 Catalog Number :

Device Description : EMPOWR PS KNEE X-RAY TEMPLATE, FEMUR

Device Class : 1

Duns Number: 154074504

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

DJO SURGICAL - 00190446137498 Catalog Number :

Device Description : DISC ULNA 3X155MM LT W/BRNG C

Device Class : 2

Duns Number: 154074504

Premarket Exempt : No

Product Code : JDC

Prescription Use : No

Device Count : 1

DJO SURGICAL - 00190446137504 Catalog Number :

Device Description : DISC ULNA 4X155MM LT W/BRNG C

Device Class : 2

Duns Number: 154074504

Premarket Exempt : No

Product Code : JDC

Prescription Use : No

Device Count : 1

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