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

Orthopedic Manual Surgical Instrument (LXH) (9) Impactor (HWA) (1)

Premarket Exempt

Yes

Clear

High Offset Reamer Handle - Stryker Z/H Tri-coupling - 07630055300010 Catalog Number : 1440-4010

Device Description : 50° 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 Reamer Handle - Jacobs - Dual Coupling - 07630055300027 Catalog Number : 131-171E

Device Description : Straight reamer handle - Jacobs - Dual coupling

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Straight Reamer Handle - Large AO - Dual Coupling - 07630055300034 Catalog Number : 131-171D

Device Description : Straight Reamer Handle - Large AO - Dual 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 - Dual Coupling - 07630055300041 Catalog Number : 131-171H

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

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Straight Reamer Handle - Hudson - Dual Coupling - 07630055300058 Catalog Number : 131-171B

Device Description : Straight Reamer Handle - Hudson - Dual Coupling

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Offset Reamer Handle - Dual Coupling - 07630055300065 Catalog Number : 131-174/05

Device Description : Offset Reamer Handle system, without motor coupling

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Large AO motor shaft - Offset Reamer Handle - 07630055300072 Catalog Number : 131-174/04D

Device Description : Large AO motor shaft for offset reamer handle

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Stryker Z/H motor shaft - Offset Reamer Handle - 07630055300089 Catalog Number : 131-174/04H

Device Description : Stryker Z/H motor shaft - Offset Reamer Handle

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Hudson motor shaft - Offset Reamer Handle - 07630055300096 Catalog Number : 131-174/04B

Device Description : Hudson motor shaft - Offset Reamer Handle

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Offset Cup Impactor - M8x1.25 Interface - 07630055300102 Catalog Number : 183-151/00

Device Description : Offset Cup Impactor - M8x1.25 Interface

Device Class : 1

Duns Number: 485098284

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

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