EZSTART - EZStart Interference Screw, 8mm x 25mm, Titanium - Conmed Corporation

Duns Number:071595540

Device Description: EZStart Interference Screw, 8mm x 25mm, Titanium

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More Product Details

Catalog Number

EZ0825T

Brand Name

EZSTART

Version/Model Number

EZ0825T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K182955,K933352

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

39846453-9f05-4643-9402-dd686b1780ed

Public Version Date

September 27, 2019

Public Version Number

3

DI Record Publish Date

October 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95