Bioretec Oy

Address:Yrittajankulma 5,Tampere Pirkanmaa,FI

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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

Fastener, Fixation, Biodegradable, Soft Tissue (MAI) (10)

Premarket Exempt

No Yes

Clear

TorqLoc Interference - E30210100909289 Catalog Number : 10-1009-0928

Device Description : TorqLoc Interference 9 x 28 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

TorqLoc Interference - E30210100909309 Catalog Number : 10-1009-0930

Device Description : TorqLoc Interference 9 x 30 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

TorqLoc Interference - E30210100909339 Catalog Number : 10-1009-0933

Device Description : TorqLoc Interference 9 x 33 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

TorqLoc Interference - E30210100910249 Catalog Number : 10-1009-1024

Device Description : TorqLoc Interference 10 x 24 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

TorqLoc Interference - E30210100910289 Catalog Number : 10-1009-1028

Device Description : TorqLoc Interference 10 x 28 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

TorqLoc Interference - E30210100910309 Catalog Number : 10-1009-1030

Device Description : TorqLoc Interference 10 x 30 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

TorqLoc Interference - E30210100910339 Catalog Number : 10-1009-1033

Device Description : TorqLoc Interference 10 x 33 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI04109 Catalog Number : B-AI-0410

Device Description : ActivaScrew™ Interference 4 x 10 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI04159 Catalog Number : B-AI-0415

Device Description : ActivaScrew™ Interference 4 x 15 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI04209 Catalog Number : B-AI-0420

Device Description : ActivaScrew™ Interference 4 x 20 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

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