LineSider - Offset Iliac Connector, 15mm - 5.5 / 6.0 Rod - Integrity Implants Inc.

Duns Number:080300717

Device Description: Offset Iliac Connector, 15mm - 5.5 / 6.0 Rod

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More Product Details

Catalog Number

LS-IC55T15

Brand Name

LineSider

Version/Model Number

LS-IC55T15

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

K190360

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

6fd48d96-4c6a-4923-8306-de07c1cfab77

Public Version Date

May 13, 2022

Public Version Number

2

DI Record Publish Date

October 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRITY IMPLANTS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 787
2 A medical device with a moderate to high risk that requires special controls. 1255