Royal Oak IBFD Implant System

GUDID 00812352021288

Royal Oak IBFD Instrument Set Case 1

Royal Oak Medical Devices LLC

External spinal fixation system

• Primary Device ID: 00812352021288
• NIH Device Record Key: 0d7084c7-edcd-46eb-be5c-ca8ddd554748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Royal Oak IBFD Implant System
• Version Model Number: 4501081
• Company DUNS: 017825896
• Company Name: Royal Oak Medical Devices LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 248-853-1450
• Email: customerservice@royaloakmed.com
• Phone: 248-853-1450
• Email: customerservice@royaloakmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812352021288 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00812352021288]

Moist Heat or Steam Sterilization

[00812352021288]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-22

On-Brand Devices [Royal Oak IBFD Implant System]

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