APTIS MEDICAL, LLC

Address:3602 Glenview Ave,Glenview,KY,40025,US

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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

Prosthesis, Wrist, Hemi-, Ulnar (KXE) (8) Guide, Surgical, Instrument (FZX) (1) Tray, Surgical (LRP) (1)

Premarket Exempt

Yes No

Clear

Scheker DRUJ - B013DRUJKWD0 Catalog Number : DRUJ-KWD

Device Description : K-Wire Dispenser 6 3/4"

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Scheker Prosthesis - B013DRUJLDG250 Catalog Number :

Device Description : Locking Drill Guide 2.5mm

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : No

Device Count : 1

NA - B013DRUJLP100 Catalog Number : DRUJ-LP10

Device Description : Distal Radio-Ulnar Joint Locking Plate Assembly, Size 10

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLP200 Catalog Number : DRUJ-LP20

Device Description : Distal Radio-Ulnar Joint Locking Plate Assembly, Size 20

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLSC100 Catalog Number : DRUJ-LSC10

Device Description : 10 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLSC120 Catalog Number : DRUJ-LSC12

Device Description : 12 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLSC140 Catalog Number : DRUJ-LSC14

Device Description : 14 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLSC160 Catalog Number : DRUJ-LSC16

Device Description : 16 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLSC180 Catalog Number : DRUJ-LSC18

Device Description : 18 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLSC200 Catalog Number : DRUJ-LSC20

Device Description : 20 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

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