3.5mm x 20mm Ti Cortical Screw TCX35020

GUDID B562TCX35020US0

Wishbone Medical, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TCX35020US0
NIH Device Record Key9f8ba155-cce2-4aae-becd-748ca2018b58
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 20mm Ti Cortical Screw
Version Model NumberTCX35020-US
Catalog NumberTCX35020
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
HIBCCB562TCX35020US0 [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 20mm Ti Cortical Screw ]

B562TCX350200TCX35020
B562TCX35020US0TCX35020-US

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