Reform TI Pedicle Screw System - Ø10.5 x 50mm Modular Bone Screw, Non-Fluted - PRECISION SPINE, INC.

Duns Number:079398589

Device Description: Ø10.5 x 50mm Modular Bone Screw, Non-Fluted

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More Product Details

Catalog Number

39-SG-1050

Brand Name

Reform TI Pedicle Screw System

Version/Model Number

39-SG-1050

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

K150856

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

7b598480-f765-43a5-b27b-75b4782fb2b6

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRECISION SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1423
2 A medical device with a moderate to high risk that requires special controls. 4960
U Unclassified 26