2.7mm x 10mm Ti Locking Screw

GUDID B562TLK270100

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TLK270100
NIH Device Record Keya6e8345a-b155-4049-9227-71a0b06ac302
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.7mm x 10mm Ti Locking Screw
Version Model NumberTLK27010
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
HIBCCB562TLK270100 [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 [2.7mm x 10mm Ti Locking Screw ]

B562TLK270100TLK27010
B562TLK27010US0TLK27010-US

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