SignaLoc Screw

GUDID 09348215116927

SIGNATURE ORTHOPAEDICS PTY LTD

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID09348215116927
NIH Device Record Key269c8dfe-951d-41aa-810a-9d225d19f514
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignaLoc Screw
Version Model Number121-18-1823
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS109348215116927 [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 Date2023-06-05
Device Publish Date2023-05-26

On-Brand Devices [SignaLoc Screw]

09348215117023121-18-1037
09348215117016121-18-1032
09348215117009121-18-1027
09348215116996121-18-1023
09348215116989121-18-1937
09348215116972121-18-1932
09348215116965121-18-1927
09348215116958121-18-1923
09348215116941121-18-1832
09348215116934121-18-1827
09348215116927121-18-1823
09348215116910121-18-1732
09348215116903121-18-1727
09348215116897121-18-1723
09348215116880121-18-1627
09348215116873121-18-0037
09348215116866121-18-0032
09348215116859121-18-0027
09348215116842121-18-0023
09348215116835121-18-0937
09348215116828121-18-0932
09348215116811121-18-0927
09348215116804121-18-0923
09348215116798121-18-0832
09348215116781121-18-0827
09348215116774121-18-0823
09348215116767121-18-0732
09348215116750121-18-0727
09348215116743121-18-0723
09348215116736121-18-0627
09348215116729121-18-0623
09348215116712121-18-1623
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