Mobi-C® Plug & Fit US - Total Cervical Disc Replacement System: Trial - LDR Spine Usa, Inc.

Duns Number:615789729

Device Description: Total Cervical Disc Replacement System: Trial

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More Product Details

Catalog Number

-

Brand Name

Mobi-C® Plug & Fit US

Version/Model Number

MB9015R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MJO

Product Code Name

Prosthesis, Intervertebral Disc

Device Record Status

Public Device Record Key

6fb1db86-295b-4c52-b34a-660af031c70c

Public Version Date

March 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LDR SPINE USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 433
2 A medical device with a moderate to high risk that requires special controls. 2452
3 A medical device with high risk that requires premarket approval 61
U Unclassified 40