LDR Spine Usa, Inc.

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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

Tray, Surgical (LRP) (4) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (2)

Premarket Exempt

No Yes

Clear

ROI-C - 03662663047432 Catalog Number : SI-ROIC-0116

Device Description : ROI-C Lordotic Rounded Tooth Trial 12x14 H5

Device Class : 2

Duns Number: 615789729

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

ROI-C - 03662663047449 Catalog Number : SI-ROIC-0117

Device Description : ROI-C Lordotic Rounded Tooth Trial 12x14 H6

Device Class : 2

Duns Number: 615789729

Premarket Exempt : No

Product Code : OVE

Prescription Use : Yes

Device Count : 1

VerteFIT - 03662663049238 Catalog Number : VF990-CR

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

VerteFIT - 03662663049276 Catalog Number : VF991A-CR

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

VerteFIT - 03662663049283 Catalog Number : VF991B-CR

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

VerteFIT - 03662663049290 Catalog Number : VF991C-CR

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

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