Streamline TL Spinal Fixation System - Laminar Hook, Offset Right - Pioneer Surgical Technology, Inc.

Duns Number:793384496

Device Description: Laminar Hook, Offset Right

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More Product Details

Catalog Number

01-LHO-R

Brand Name

Streamline TL Spinal Fixation System

Version/Model Number

01-LHO-R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K192800

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

52eeaf2d-6320-44cf-8408-011d8004985f

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

June 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PIONEER SURGICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3116
2 A medical device with a moderate to high risk that requires special controls. 5221