3.5mm x 16mm Ti Locking Screw TLK35016

GUDID B562TLK35016US0

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TLK35016US0
NIH Device Record Key1e0eb42c-4d87-4cbe-8c35-a73ba02d9b43
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 16mm Ti Locking Screw
Version Model NumberTLK35016-US
Catalog NumberTLK35016
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
HIBCCB562TLK35016US0 [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 Number2
Public Version Date2022-01-17
Device Publish Date2019-11-25

On-Brand Devices [3.5mm x 16mm Ti Locking Screw ]

B562TLK350160TLK35016
B562TLK35016US0TLK35016-US

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