Paeon Posterior Cervical Fixation System - Cervical Semi Reduction Screw Ø5.0x20mm (Ø3.5 - Aegis Spine, Inc.

Duns Number:017993061

Device Description: Cervical Semi Reduction Screw Ø5.0x20mm (Ø3.5 Neck)

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More Product Details

Catalog Number

6202-5020S

Brand Name

Paeon Posterior Cervical Fixation System

Version/Model Number

6202-5020S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K221050

Product Code Details

Product Code

NKG

Product Code Name

Posterior Cervical Screw System

Device Record Status

Public Device Record Key

29e3007c-dd70-47dc-841a-9ce93ac5dfca

Public Version Date

September 06, 2022

Public Version Number

1

DI Record Publish Date

August 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AEGIS SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 85
2 A medical device with a moderate to high risk that requires special controls. 1905