Synthes GmbH

Address:Industriestrasse 28,Selzach Solothurn,CH

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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

Staple, Fixation, Bone (JDR) (7) Kit, Surgical Instrument, Disposable (KDD) (3)

Premarket Exempt

No Yes

Clear

Elite - 00810633021712 Catalog Number : EL3020S4

Device Description : ELITE 30x20x20mm, Straight Bridge, 4 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021767 Catalog Number : EL201507Y3

Device Description : ELITE 20x15x7mm, Y-Shaped Bridge, 3 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021774 Catalog Number : EL202007Y3

Device Description : ELITE 20x20x7mm, Y-Shaped Bridge, 3 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021781 Catalog Number : EL251507Y4

Device Description : ELITE 25x15x7mm, Y-Shaped Bridge, 4 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021798 Catalog Number : EL252007Y4

Device Description : ELITE 25x20x7mm, Y-Shaped Bridge, 4 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021804 Catalog Number : EL301507Y4

Device Description : ELITE 30x15x7mm, Y-Shaped Bridge, 4 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021811 Catalog Number : EL302007Y4

Device Description : ELITE 30x20x7mm, Y-Shaped Bridge, 4 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Hand and Wrist - 00810633021835 Catalog Number : DK200HW

Device Description : Drill Kit for Speed Hand and Wrist System

Device Class : 1

Duns Number: 480426451

Premarket Exempt : No

Product Code : KDD

Prescription Use : Yes

Device Count : 1

Elite - 00810633021958 Catalog Number : DK300

Device Description : BME ELITE INSTRUMENT KIT

Device Class : 1

Duns Number: 480426451

Premarket Exempt : No

Product Code : KDD

Prescription Use : Yes

Device Count : 1

Elite - 00810633021965 Catalog Number : ELDTS

Device Description : BME ELITE S-SERIES DRILLING TEMPLATE KIT

Device Class : 1

Duns Number: 480426451

Premarket Exempt : No

Product Code : KDD

Prescription Use : Yes

Device Count : 1

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