APEX-DL Spine System - APEX-DL X-Large Polyaxial Screw Dia. 8.50 x 60mm, - SPINECRAFT, LLC

Duns Number:783908713

Device Description: APEX-DL X-Large Polyaxial Screw Dia. 8.50 x 60mm, Self-tapping

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More Product Details

Catalog Number

DPF6-8560-XL

Brand Name

APEX-DL Spine System

Version/Model Number

DPF6-8560-XL

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"

Yes

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

-

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

70469ce1-fea9-44a0-b04f-5db0f9f9e2f9

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINECRAFT, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1247
2 A medical device with a moderate to high risk that requires special controls. 15504