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 - 00810633020104 Catalog Number : SE0907

Device Description : SPEED 9X7X7mm implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020111 Catalog Number : SE0910

Device Description : SPEED 9X10X10mm implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020128 Catalog Number : SE1110

Device Description : SPEED 11X10X10mm implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020135 Catalog Number : SE111513

Device Description : SPEED 11X15X13mm implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020142 Catalog Number : SE1310

Device Description : SPEED 13X10X10mm implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020159 Catalog Number : SE131513

Device Description : SPEED 13X15X13mm implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020166 Catalog Number : SE1512

Device Description : SPEED 15X12X12mm implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Shift - 00810633020425 Catalog Number : SE152006

Device Description : Speed Shift 15x20x20 Offset 6mm Implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Shift - 00810633020432 Catalog Number : SE152008

Device Description : Speed Shift 15x20x20 Offset 8mm Implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed Shift - 00810633020449 Catalog Number : SE152010

Device Description : Speed Shift 15x20x20 Offset 10mm Implant

Device Class : 2

Duns Number: 480426451

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

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