Helical Ridge

GUDID M970140020047500

4.75MM X 20MM PEEK Interference Screw

Medshape, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDM970140020047500
NIH Device Record Keyd8ce6c2d-1359-4ea0-aecf-bb58b12c07af
Commercial Distribution Discontinuation2023-06-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHelical Ridge
Version Model Number1400-20-0475
Company DUNS601306413
Company NameMedshape, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM970140020047500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-06-27
Device Publish Date2017-02-13

On-Brand Devices [Helical Ridge]

M97024000502006Quick Connect Driver, 2.0 Reverse Threaded
M9701400200475004.75MM X 20MM PEEK Interference Screw
M9701400170475004.75MM X 17.5MM PEEK Interference Screw
M9701400150475004.75MM X 15MM PEEK Interference Screw

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