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

ActivaScrew™ Interference - E302BAI05109 Catalog Number : B-AI-0510

Device Description : ActivaScrew™ Interference 5 x 10 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI05159 Catalog Number : B-AI-0515

Device Description : ActivaScrew™ Interference 5 x 15 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI05209 Catalog Number : B-AI-0520

Device Description : ActivaScrew™ Interference 5 x 20 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI06159 Catalog Number : B-AI-0615

Device Description : ActivaScrew™ Interference 6 x 15 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI06209 Catalog Number : B-AI-0620

Device Description : ActivaScrew™ Interference 6 x 20 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI06269 Catalog Number : B-AI-0626

Device Description : ActivaScrew™ Interference 6 x 26 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI07209 Catalog Number : B-AI-0720

Device Description : ActivaScrew™ Interference 7 x 20 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI07249 Catalog Number : B-AI-0724

Device Description : ActivaScrew™ Interference 7 x 24 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI07269 Catalog Number : B-AI-0726

Device Description : ActivaScrew™ Interference 7 x 26 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ActivaScrew™ Interference - E302BAI07309 Catalog Number : B-AI-0730

Device Description : ActivaScrew™ Interference 7 x 30 mm

Device Class : 2

Duns Number: 368715301

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

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