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

Prosthesis, Intervertebral Disc (MJO) (6) Orthopedic Manual Surgical Instrument (LXH) (4)

Premarket Exempt

No Yes

Clear

Mobi-C - 03662663000406 Catalog Number : MB946R

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Mobi-C - 03662663000413 Catalog Number : MB947R

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Mobi-C - 03662663000420 Catalog Number : MB948R

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Mobi-C - 03662663000437 Catalog Number : MB949R

Device Class : 1

Duns Number: 615789729

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Mobi-C® Plug & Fit US - 03662663000741 Catalog Number :

Device Description : Total Cervical Disc Replacement System: Universal Inserter

Device Class : 3

Duns Number: 615789729

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

Mobi-C® Plug & Fit US - 03662663000819 Catalog Number :

Device Description : Total Cervical Disc Replacement System: Trial

Device Class : 3

Duns Number: 615789729

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

Mobi-C® Plug & Fit US - 03662663000826 Catalog Number :

Device Description : Total Cervical Disc Replacement System: Trial

Device Class : 3

Duns Number: 615789729

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

Mobi-C® Plug & Fit US - 03662663000833 Catalog Number :

Device Description : Total Cervical Disc Replacement System: Trial

Device Class : 3

Duns Number: 615789729

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

Mobi-C® Plug & Fit US - 03662663000864 Catalog Number :

Device Description : Total Cervical Disc Replacement System: Trial

Device Class : 3

Duns Number: 615789729

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

Mobi-C® Plug & Fit US - 03662663000871 Catalog Number :

Device Description : Total Cervical Disc Replacement System: Trial

Device Class : 3

Duns Number: 615789729

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

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