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) (5) Template (HWT) (3) Bit, Drill (HTW) (1) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

Yes No

Clear

NA - B013DRUJLSC220 Catalog Number : DRUJ-LSC22

Device Description : 22 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJLSC240 Catalog Number : DRUJ-LSC24

Device Description : 24 mm 3.5 Locking Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJMB10200 Catalog Number : DRUJ-MB1020

Device Description : Black Measuring Device Ball

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJMB300 Catalog Number : DRUJ-MB30

Device Description : Blue Measuring Device Ball

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJMD1000 Catalog Number : DRUJ-MD100

Device Description : Ulna Resection Measuring Device

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : No

Device Count : 1

NA - B013DRUJP200 Catalog Number : DRUJ-P20

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

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

NA - B013DRUJP300 Catalog Number : DRUJ-P30

Device Description : Distal Radio-Ulnar Joint Plate Assembly, Size 30

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJPB1000 Catalog Number : DRUJ-PB100

Device Description : Radial Peg Drill Bit

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : No

Device Count : 1

Scheker DRUJ - B013DRUJQCEXT1000 Catalog Number : DRUJ-QCEXT

Device Description : Quick Connect Extension

Device Class : 1

Duns Number: 780455338

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NA - B013DRUJRPCS1000 Catalog Number : DRUJ-RPCS100

Device Description : Radial Plate Cover Screw

Device Class : 2

Duns Number: 780455338

Premarket Exempt : No

Product Code : KXE

Prescription Use : No

Device Count : 1

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