3.5mm x 34mm Ti Locking Screw

GUDID B562TLK350340

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TLK350340
NIH Device Record Key4732c39b-256c-434a-b617-a816ae89f7ee
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 34mm Ti Locking Screw
Version Model NumberTLK35034
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
HIBCCB562TLK350340 [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 34mm Ti Locking Screw ]

B562TLK350340TLK35034
B562TLK35034US0TLK35034-US

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