3.5mm x 32mm Ti Locking Screw TLK35032

GUDID B562TLK35032US0

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TLK35032US0
NIH Device Record Key5fb5213c-c8e6-42c5-b96e-847221cdb383
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 32mm Ti Locking Screw
Version Model NumberTLK35032-US
Catalog NumberTLK35032
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
HIBCCB562TLK35032US0 [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 32mm Ti Locking Screw ]

B562TLK350320TLK35032
B562TLK35032US0TLK35032-US

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