Plate Holder (manufactured from 630 S/S)

GUDID 09348215051426

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Orthopaedic implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID09348215051426
NIH Device Record Keyf4d68521-c7be-4a40-b286-57443a3e78ec
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlate Holder (manufactured from 630 S/S)
Version Model NumberI32-02-0008
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
GS109348215051426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


[09348215051426]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-06
Device Publish Date2019-06-06

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215129224 - Verteloc Lumbar Cage 2024-03-20
09348215129231 - Verteloc Lumbar Cage 2024-03-20
09348215129248 - Verteloc Lumbar Cage 2024-03-20
09348215129255 - Verteloc Lumbar Cage 2024-03-20
09348215129262 - Verteloc Lumbar Cage 2024-03-20
09348215129279 - Verteloc Lumbar Cage 2024-03-20
09348215129286 - Verteloc Lumbar Cage 2024-03-20
09348215129293 - Verteloc Lumbar Cage 2024-03-20

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