OSTEOMED LLC

Address:3885 Arapaho Rd,ADDISON,TX,75001,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) (1) Screw, fixation, bone (HWC) (1)

Premarket Exempt

No Yes

Clear

OsteoMed - 00845694098427 Catalog Number : 336-6214

Device Description : 14H Distal Fibula Plate, Right

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

OsteoMed - 00845694098434 Catalog Number : 316-0034

Device Description : Cannulated Non-Slip Screwdriver Body, 6.5/7.3mm

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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