SYNTHES (U.S.A.) LP

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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

PLATE, BONE (JEY) (6) TRAY, SURGICAL, INSTRUMENT (FSM) (3) FORCEPS (HTD) (1)

Premarket Exempt

No Yes

Clear

NA - 10887587057460 Catalog Number : 60500006

Device Description : MODULE FOR ORTHODONTIC BONE ANCHOR (OBA) SYSTEM

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

NA - 10887587060064 Catalog Number : 690605

Device Description : STERNAL FIXATION SYSTEM GRAPHIC CASE

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

NA - 10887587060453 Catalog Number : 690660

Device Description : GRAPHIC CASE FOR MANDIBLE MODULAR FIXTN SYSTEM 4 H LONG

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

NA - 10887587066578 Catalog Number : SD447200

Device Description : 2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/8MM BAR

Device Class :

Duns Number: 832637081

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

NA - 10887587066585 Catalog Number : SD447201

Device Description : 2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/10MM BAR

Device Class :

Duns Number: 832637081

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

NA - 10887587066592 Catalog Number : SD447202

Device Description : 2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/12MM BAR

Device Class :

Duns Number: 832637081

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

NA - 10887587066608 Catalog Number : SD447203

Device Description : 2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/14MM BAR

Device Class :

Duns Number: 832637081

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

NA - 10887587066615 Catalog Number : SD447204

Device Description : 2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/16MM BAR

Device Class :

Duns Number: 832637081

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

NA - 10887587066622 Catalog Number : SD447199

Device Description : 2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/6MM BAR

Device Class :

Duns Number: 832637081

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

NA - 10887587076867 Catalog Number : SD347981

Device Description : IPS PLATE HOLDING FORCEPS

Device Class : 1

Duns Number: 832637081

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : Yes

Device Count : 1

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