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

HANDPIECE, ROTARY BONE CUTTING (KMW) (5) DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) (HBE) (3) Screw, fixation, bone (HWC) (2)

Premarket Exempt

No Yes

Clear

OsteoMed - 00842528100097 Catalog Number : 111-1646

Device Description : 1.6mm Pilot Drill, Long Cannula, Hex

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100103 Catalog Number : 114-1616

Device Description : 1.6mm Driver Stem w/Post, Short, Hex

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100110 Catalog Number : 114-1622

Device Description : 1.6mm Driver Stem w/Post, Medium, Hex

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100127 Catalog Number : 114-1634

Device Description : 1.6mm Driver Stem w/Post, Long, Hex

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100134 Catalog Number : 114-2016

Device Description : 2.0mm Driver Stem w/Post, Short, Hex

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100141 Catalog Number : 114-2022

Device Description : 2.0mm Driver Stem w/Post, Medium, Hex

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100158 Catalog Number : 114-2034

Device Description : 2.0mm Driver Stem w/Post, Long, Hex

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : KMW

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100165 Catalog Number : 222-2066

Device Description : Compact Neuro Block

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100196 Catalog Number : 317-4520

Device Description : 4.5 x 20 mm Cannulated Headless Compression Screw, Short Thread

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100202 Catalog Number : 317-4522

Device Description : 4.5 x 22 mm Cannulated Headless Compression Screw, Short Thread

Device Class : 2

Duns Number: 606417780

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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