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) (6) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (2) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (2)

Premarket Exempt

No Yes

Clear

SureMAX-SA - 00817662026008 Catalog Number : 1022-11220

Device Description : Lock Cam Opener

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026015 Catalog Number : 1022-01

Device Description : SureMAX-SA Sterlization Tray — Lid

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026022 Catalog Number : 1022-02

Device Description : SureMAX-SA Sterilization Tray — Base

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026039 Catalog Number : 1022-2801

Device Description : Helical screw tip

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026220 Catalog Number : 1022-2901

Device Description : Short Handled Driver

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026237 Catalog Number : 1022-3001

Device Description : AO Drill, Medium-16

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026244 Catalog Number : 1022-3101

Device Description : AO Drill, Large-18

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026251 Catalog Number : 1022-3201

Device Description : AO Drill, EX-Large-20

Device Class : 1

Duns Number: 057002266

Premarket Exempt : No

Product Code : LYQ

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026268 Catalog Number : 1322-RFS14

Device Description : SureMAX-SA – Rescue Fixed Angle Bone Screw –14

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

SureMAX-SA - 00817662026275 Catalog Number : 1322-RFS16

Device Description : SureMAX-SA – Rescue Fixed Angle Bone Screw –16

Device Class : 2

Duns Number: 057002266

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

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