Trial Neck

GUDID 09348215051327

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215051327
NIH Device Record Key14d23773-a463-425b-9952-6f6b7d7f3684
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Neck
Version Model Number111-28-0017
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
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 Usefalse
Lot Batchtrue
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
GS109348215051327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215051327]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-04
Device Publish Date2019-06-06

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09348215110260 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110277 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110284 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110291 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110307 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110314 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20

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