aap Implantate AG

Address:LORENZWEG 5,BERLIN,DE

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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) (4) IMPACTOR (HWA) (2) REAMER (HTO) (2) Guide, surgical, instrument (FZX) (1) WRENCH (HXC) (1)

Premarket Exempt

No Yes

Clear

NA - 04042409035647 Catalog Number :

Device Description : APS triple drill reamer complete

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

NA - 04042409035685 Catalog Number :

Device Description : APS triple drill reamer complete, short (condylar)

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : HTO

Prescription Use : Yes

Device Count : 1

NA - 04042409035753 Catalog Number :

Device Description : APS wrench

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : HXC

Prescription Use : Yes

Device Count : 1

NA - 04042409035807 Catalog Number :

Device Description : APS impactor

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

NA - 04042409035845 Catalog Number :

Device Description : Plastic tip for impactor

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : HWA

Prescription Use : Yes

Device Count : 1

NA - 04042409035876 Catalog Number :

Device Description : APS connecting screw long, explantation

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 04042409035906 Catalog Number :

Device Description : APS centering sleeve, short

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 04042409035913 Catalog Number :

Device Description : APS guide rod

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

NA - 04042409035920 Catalog Number :

Device Description : APS connecting screw

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 04042409035937 Catalog Number :

Device Description : APS centering sleeve, long

Device Class : 1

Duns Number: 328420633

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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