NCS LAB SRL

Address:Via Pola Esterna 4/12,Carpi Modena,IT

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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) (8) Exerciser, Measuring (ISD) (2)

Premarket Exempt

No Yes

Clear

SPINE KIT – 3 WISE - 08051122041084 Catalog Number :

Device Description : The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine and the head.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Software web Showmotion - 08051122041091 Catalog Number :

Device Description : Showmotion software can be used to control motion sensors hardware in order to t Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Taylor Stitcher body - 08051122041121 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Elite Spk inserter - 08051122041138 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Taylor Stitcher Punch - 08051122041145 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Taylor Stitcher Screwdriver - 08051122041152 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Taylor Stitcher Targeting system - 08051122041169 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Taylor Stitcher Screw ring main body - 08051122041176 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Taylor Stitcher Screws - 08051122041183 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Taylor Stitcher Sterilization basket - 08051122041190 Catalog Number :

Device Description : Surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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