Procedure Kit Straight Fibula Plate 8 hole 3.5mm Cortical Screws Ti

GUDID B562PKSFP3508T0

WISHBONE MEDICAL, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Primary Device IDB562PKSFP3508T0
NIH Device Record Key95e4158b-bbfe-469a-a644-c83080a1979b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcedure Kit Straight Fibula Plate 8 hole 3.5mm Cortical Screws Ti
Version Model NumberPK-SFP3508T
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB562PKSFP3508T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-16
Device Publish Date2019-09-06

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