3.5mm x 8mm Ti Cortical Screw

GUDID B562TCX350080

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TCX350080
NIH Device Record Key6441663a-5847-4aeb-b28e-badaac9ccc41
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 8mm Ti Cortical Screw
Version Model NumberTCX35008
Company DUNS062355158
Company NameWISHBONE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
HIBCCB562TCX350080 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-15

On-Brand Devices [3.5mm x 8mm Ti Cortical Screw ]

B562TCX350080TCX35008
B562TCX35008US0TCX35008-US

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.