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) (10)

Premarket Exempt

No Yes

Clear

SureMAX-SA - 00817662025803 Catalog Number : 1022-702

Device Description : AWL GUIDE SIZE 7

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025810 Catalog Number : 1022-802

Device Description : AWL GUIDE SIZE 8

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025827 Catalog Number : 1022-902

Device Description : AWL GUIDE SIZE 9

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025834 Catalog Number : 1022-1002

Device Description : AWL GUIDE SIZE 10

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025841 Catalog Number : 1022-1102

Device Description : AWL GUIDE SIZE 11

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025858 Catalog Number : 1022-1202

Device Description : AWL GUIDE SIZE 12

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025865 Catalog Number : 1022-1301

Device Description : ANGLED SHAFT

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025872 Catalog Number : 1022-1401

Device Description : INNER SHAFT FOR ANGLED SHAFT

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025889 Catalog Number : 1022-1501

Device Description : DRILL TIP

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662025896 Catalog Number : 1022-1601

Device Description : DRIVER TIP

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

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