MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC

Address:234 E. 1st Street,Casper,WY,82601,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

Plate, Fixation, Bone (HRS) (10)

Premarket Exempt

Clear

Level Action Plate System - B666MCG100AO200 Catalog Number : MCG100AO-20

Device Description : 2.0MM DRILL BIT – AO

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Level Action Plate System - B666MCG100AO250 Catalog Number : MCG100AO-25

Device Description : 2.5MM DRILL BIT - AO

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Lever Action Plate System - B666MCG90000 Catalog Number : MCG9000

Device Description : VOLAR TILT/BEAM SCREW DEPTH GUAGE

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Lever Action Plate System - B666MCG90010 Catalog Number : MCG9001

Device Description : DRILL BIT GUIDE

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Lever Action Plate System - B666MCG90020 Catalog Number : MCG9002

Device Description : BEAM AWL PIN GUIDE

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Lever Action Plate System - B666MCG90030 Catalog Number : MCG9003

Device Description : GUIDE BLOCK LOCK SCREW

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Level Action Plate System - B666MCG90040 Catalog Number : MCG9004

Device Description : Hohmann retractor, 6'', 15.0mm wide blade, flat handle

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Level Action Plate System - B666MCG90050 Catalog Number : MCG9005

Device Description : Key periosteal elevator, 6 7/8'', slightly curved, 3.0mm wide blade, hexagonal handle

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Level Action Plate System - B666MCG90060 Catalog Number : MCG9006

Device Description : Ambler ingrown tissue hook, 6'', curved, sharp prong, round handle

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Lever Action Plate System - B666MCG90070 Catalog Number : MCG9007

Device Description : Bone reduction forceps, 5 1/4'', curved, one tip with stepped point, ring handle

Device Class : 2

Duns Number: 078568266

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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