Royal Oak IBFD Implant System

GUDID 00812352020755

Parallel PLIF Cage 22mm x 14mm

Royal Oak Medical Devices LLC

Polymeric spinal interbody fusion cage
Primary Device ID00812352020755
NIH Device Record Key0f662b1c-d074-4afe-81ab-635181af27cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoyal Oak IBFD Implant System
Version Model NumberPP221014-0001
Company DUNS017825896
Company NameRoyal Oak Medical Devices LLC
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 Usetrue
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

Customer Support Contacts

Phone248-853-1450
Emailcustomerservice@royaloakmed.com
Phone248-853-1450
Emailcustomerservice@royaloakmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812352020755 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812352020755]

Moist Heat or Steam Sterilization


[00812352020755]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2015-09-22

On-Brand Devices [Royal Oak IBFD Implant System]

00812352021295Royal Oak IBFD Instrument Set Case 2
00812352021288Royal Oak IBFD Instrument Set Case 1
00812352020908TLIF Cage 25mm x 16mm
00812352020892TLIF Cage 25mm x 14mm
00812352020885TLIF Cage 25mm x 12mm
00812352020878TLIF Cage 25mm x 10mm
00812352020861TLIF Cage 25mm x 8mm
00812352020816Parallel PLIF Cage 26mm x 16mm
00812352020809Parallel PLIF Cage 26mm x 14mm
00812352020793Parallel PLIF Cage 26mm x 12mm
00812352020786Parallel PLIF Cage 26mm x 10mm
00812352020779Parallel PLIF Cage 26mm x 8mm
00812352020762Parallel PLIF Cage 22mm x 16mm
00812352020755Parallel PLIF Cage 22mm x 14mm
00812352020748Parallel PLIF Cage 22mm x 12mm
00812352020731Parallel PLIF Cage 22mm x 10mm
00812352020724Parallel PLIF Cage 22mm x 8mm

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