Trial Cage 15deg 16M

GUDID 09348215066628

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215066628
NIH Device Record Key3d516a7d-3e14-4820-b048-a5c166c2635b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Cage 15deg 16M
Version Model Number135-15-0053
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
GS109348215066628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


[09348215066628]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-08
Device Publish Date2020-06-30

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215110246 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110253 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.