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) (10)

Premarket Exempt

No Yes

Clear

Speed Triad - 00810633021590 Catalog Number : SE181508TRL

Device Description : Speed Triad 18X15X08mm 3 Legs, left offset

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Triad - 00810633021606 Catalog Number : SE181508TRR

Device Description : Speed Triad 18X15X08mm 3 Legs, right offset

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Triad - 00810633021613 Catalog Number : SE181508TRC

Device Description : Speed Triad 18X15X08mm 3 Legs, centered

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Triad - 00810633021620 Catalog Number : SE201508TRL

Device Description : Speed Triad 20X15X08mm 3 Legs, left offset

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Triad - 00810633021637 Catalog Number : SE201508TRR

Device Description : Speed Triad 20X15X08mm 3 Legs, right offset

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Triad - 00810633021644 Catalog Number : SE201508TRC

Device Description : Speed Triad 20X15X08mm 3 Legs, centered

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021675 Catalog Number : EL1515S2

Device Description : ELITE 15x15x15mm, Straight Bridge, 2 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021682 Catalog Number : EL1818S2

Device Description : ELITE 18x18x18mm, Straight Bridge, 2 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021699 Catalog Number : EL2020S2

Device Description : ELITE 20x20x20mm, Straight Bridge, 2 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Elite - 00810633021705 Catalog Number : EL2520S4

Device Description : ELITE 25x20x20mm, Straight Bridge, 4 Legs

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

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