Catalog Number

FP25028

Brand Name

TwistCut™ EndoSorb bioabsorbable Snap-Off Screw

Version/Model Number

2.5 28

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2020

Issuing Agency

In GS1

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

K102777

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

81c68446-912d-4900-9960-72bedd3a13ef

Public Version Date

November 18, 2020

Public Version Number

5

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-