SpineTune TL - CAN. POLY.REDUC. SCREW 5.5 L35 - LDR Spine Usa, Inc.

Duns Number:615789729

Device Description: CAN. POLY.REDUC. SCREW 5.5 L35

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More Product Details

Catalog Number

-

Brand Name

SpineTune TL

Version/Model Number

ST7252T-S

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

Yes

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

K102331

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

9b373cfb-67d4-4466-a41e-70793933ca61

Public Version Date

March 10, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2015

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