Incipio Devices SA

Address:Av. des Paquiers 16,St Blaise Neuchatel,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

Reamer (HTO) (6) Orthopedic Manual Surgical Instrument (LXH) (4)

Premarket Exempt

Yes

Clear

Offset Reamer Handle - Stryker Z/H - Tri-coupling - 07630055300119 Catalog Number : 50245112

Device Description : Offset Reamer Handle - Stryker Z/H - Tri-coupling

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Straight Reamer Handle - Stryker Z/H - Tri-Coupling - 07630055300126 Catalog Number : 50245161

Device Description : Straight Reamer Handle - Stryker Z/H - Tri-Coupling

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

30 DEGREE OFFSET DEPUY AO/HUDSON ACETABULAR REAMER DRIVER - 07630055300133 Catalog Number : 481100510

Device Description : Offset Reamer Handle for hip arthroplasty

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

STRAIGHT DEPUY AO/HUDSON ACETABULAR REAMER DRIVER - 07630055300140 Catalog Number : 481100110

Device Description : Straight Reamer Handle for hip arthroplasty

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cup Reamer Size 42 - 07630055300188 Catalog Number : 3700502206685

Device Description : Acetabular reamer ø43mm for implant cup ø42mm

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Cup Reamer Size 44 - 07630055300195 Catalog Number : 3700502206692

Device Description : Acetabular reamer ø45mm for implant cup ø44mm

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Cup Reamer Size 46 - 07630055300201 Catalog Number : 3700502206708

Device Description : Acetabular reamer ø47mm for implant cup ø46mm

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Cup Reamer Size 48 - 07630055300218 Catalog Number : 3700502206715

Device Description : Acetabular reamer ø49mm for implant cup ø48mm

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Cup Reamer Size 50 - 07630055300225 Catalog Number : 3700502206722

Device Description : Acetabular reamer ø51mm for implant cup ø50mm

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

Cup Reamer Size 52 - 07630055300232 Catalog Number : 3700502206739

Device Description : Acetabular reamer ø53mm for implant cup ø52mm

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

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