ADDITIVE IMPLANTS, LLC

Address:3101 East Shea Boulevard,Phoenix,AZ,85028,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

Accessories, Fixation, Spinal Intervertebral Body (LYQ) (5) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (5)

Premarket Exempt

No Yes

Clear

SureMAX-SA - 00817662025704 Catalog Number : 1322-VS20

Device Description : SureMAX-SA – Variable Angle Bone Screw – 20

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025711 Catalog Number : 1322–HB14

Device Description : SureMAX-SA Helical Screw —14

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025728 Catalog Number : 1322–HB16

Device Description : SureMAX-SA Helical Screw —16

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025735 Catalog Number : 1322–HB18

Device Description : SureMAX-SA Helical Screw —18

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025742 Catalog Number : 1322–HB20

Device Description : SureMAX-SA Helical Screw —20

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025759 Catalog Number : 1022-10157

Device Description : Low Profile Inserter 5-7

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025766 Catalog Number : 1022-101812

Device Description : Low Profile Inserter 8-12

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025773 Catalog Number : 1022-301

Device Description : INNER SHAFT FOR INSERTER AND AWL GUIDES

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025780 Catalog Number : 1022-502

Device Description : AWL GUIDE SIZE 5

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025797 Catalog Number : 1022-602

Device Description : AWL GUIDE SIZE 6

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

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