Spartan Stem Template Set

GUDID 09348215007904

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215007904
NIH Device Record Keyc5658870-62b1-4aff-9b76-d487cfa649f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpartan Stem Template Set
Version Model Number01-050-95-0000
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215007904 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-16
Device Publish Date2022-06-08

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215039295 - Liner Impactor2026-02-09
09348215039301 - Liner Impactor2026-02-09
09348215039318 - Liner Impactor2026-02-09
09348215039325 - Liner Impactor2026-02-09
09348215039332 - Ceramic Liner Inserter Impactor Head2026-02-09
09348215039349 - Ceramic Liner Inserter Impactor Head2026-02-09
09348215039356 - Ceramic Liner Inserter Impactor Head2026-02-09
09348215039363 - Ceramic Liner Inserter Impactor Head2026-02-09

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