Gladstone ALIF Trial Cage

GUDID 09348215045265

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215045265
NIH Device Record Keyab106b9b-8c22-4799-9006-6d1fdef0d899
Commercial Distribution StatusIn Commercial Distribution
Brand NameGladstone ALIF Trial Cage
Version Model NumberW32-04-0257
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
GS109348215045265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215045265]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-07-02
Device Publish Date2018-10-05

On-Brand Devices [Gladstone ALIF Trial Cage]

09348215045326W32-04-0263
09348215045319W32-04-0262
09348215045302W32-04-0261
09348215045296W32-04-0260
09348215045289W32-04-0259
09348215045272W32-04-0258
09348215045265W32-04-0257
09348215045258W32-04-0256
09348215045241W32-04-0255
09348215045234W32-04-0254
09348215045227W32-04-0253
09348215045210W32-04-0252
09348215045203W32-04-0251
09348215045197W32-04-0250
09348215045180W32-04-0249
09348215045173W32-04-0248
09348215045166W32-04-0247
09348215045159W32-04-0246
09348215045142W32-04-0245
09348215045135W32-04-0244
09348215045128W32-04-0243
09348215045111W32-04-0242
09348215045104W32-04-0241
09348215045098W32-04-0240
09348215045081W32-04-0239
09348215045074W32-04-0238
09348215045067W32-04-0237
09348215045050W32-04-0236
09348215045043W32-04-0235
09348215045036W32-04-0234
09348215045029W32-04-0233
09348215045012W32-04-0232
09348215045005W32-04-0231
09348215044992W32-04-0230
09348215044985W32-04-0229
09348215044978W32-04-0228
09348215044961W32-04-0227
09348215044954W32-04-0226
09348215044947W32-04-0225
09348215044930W32-04-0224
09348215044923W32-04-0223
09348215044916W32-04-0222
09348215044909W32-04-0221
09348215044893W32-04-0220
09348215044886W32-04-0219
09348215044879W32-04-0218
09348215044862W32-04-0217
09348215044855W32-04-0216
09348215044848W32-04-0215
09348215044831W32-04-0214

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