3.5mm x 50mm Ti Cortical Screw TCX35050

GUDID B562TCX35050US0

Wishbone Medical, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TCX35050US0
NIH Device Record Keyef740b81-452e-49d5-9589-723949fe93f1
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 50mm Ti Cortical Screw
Version Model NumberTCX35050-US
Catalog NumberTCX35050
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
HIBCCB562TCX35050US0 [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 Number3
Public Version Date2023-04-03
Device Publish Date2019-11-25

On-Brand Devices [3.5mm x 50mm Ti Cortical Screw ]

B562TCX350500TCX35050
B562TCX35050US0TCX35050-US

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