TECRES SPA

Address:VIA ANDREA DORIA 6,VERONA Veneto,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

Template (HWT) (6) Brush, Scrub, Operating-Room (GEC) (1) Cement, Bone, Vertebroplasty (NDN) (1) Dispenser, Cement (KIH) (1) Mixer, Cement, For Clinical Use (JDZ) (1)

Premarket Exempt

No Yes

Clear

InterSpace Tapered Wedge Stem Trial XL - 08031497002323 Catalog Number :

Device Description : InterSpace Tapered Wedge Stem Trial XL is intended to be used for the selection InterSpace Tapered Wedge Stem Trial XL is intended to be used for the selection of the right size of InterSpace Tapered Wedge Stem XL to be implanted.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

RALLY All In One Cement Gun - 08031497002330 Catalog Number :

Device Description : RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (an RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : No

Device Count : 1

InterSpace Knee Trial - 08031497002347 Catalog Number :

Device Description : InterSpace Knee Trial is intended to be used for the selection of the right size InterSpace Knee Trial is intended to be used for the selection of the right size of InterSpace Knee to be implanted.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Kyphon VuE™ Bone Cement - 08031497002538 Catalog Number :

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

FEMORAL BRUSH - 08031497002668 Catalog Number :

Device Description : FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullar FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullary canal. It is intended to be used for helping the surgeons, during the fixation of artificialjoint prosthesis with the acrylic bone cement, in cleaning the femoral canal from debris after the canal has been drilled and before the cement application.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : GEC

Prescription Use : No

Device Count : 1

Cemex System Container - 08031497002675 Catalog Number :

Device Description : Cemex System Container is a container for Tecres' Cemex System that allows the m Cemex System Container is a container for Tecres' Cemex System that allows the mixing of Cemex System bone cement into Tecres' Cemex System Mixer.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : No

Device Count : 1

InterSpace Tapered Wedge Stem Trial - 08031497002866 Catalog Number :

Device Description : InterSpace Tapered Wedge Stem Trial is intended to be used for the selection of InterSpace Tapered Wedge Stem Trial is intended to be used for the selection of the right size of InterSpace Tapered Wedge Stem to be implanted.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

InterSpace Hip Trial - 08031497002873 Catalog Number :

Device Description : InterSpace Hip Trial is intended to be used for the selection of the right size InterSpace Hip Trial is intended to be used for the selection of the right size of InterSpace Hip to be implanted.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

InterSpace Hip Trial XL - 08031497002880 Catalog Number :

Device Description : InterSpace Hip Trial XL is intended to be used for the selection of the right si InterSpace Hip Trial XL is intended to be used for the selection of the right size of InterSpace Hip XL to be implanted.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

InterSpace Knee ATS Trial Kit - 08031497002897 Catalog Number :

Device Description : InterSpace Knee ATS Trial Kit is intended to be used for the selection of the ri InterSpace Knee ATS Trial Kit is intended to be used for the selection of the right size and thickness of the InterSpace Knee ATS to be implanted.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

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