Quantum Spinal Fixation System - PEDICLE HOOK, LARGE - Pioneer Surgical Technology, Inc.

Duns Number:793384496

Device Description: PEDICLE HOOK, LARGE

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More Product Details

Catalog Number

10-PH-L

Brand Name

Quantum Spinal Fixation System

Version/Model Number

10-PH-L

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

K101790,K101790

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

dc78175f-d92b-425e-b21c-3502d855d35d

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

December 21, 2019

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