Thunderbolt Plate 909014-0000

GUDID 00811714035352

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00811714035352
NIH Device Record Key5642ad92-adba-43d2-814a-01e131195abd
Commercial Distribution StatusIn Commercial Distribution
Brand NameThunderbolt Plate
Version Model Number909014-0000
Catalog Number909014-0000
Company DUNS002745858
Company NameRESPONSIVE ORTHOPEDICS LLC
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
GS100811714035352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-07
Device Publish Date2021-04-29

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