| Primary Device ID | 00812352020885 |
| NIH Device Record Key | c0d6540b-d9b0-43fe-8561-9d04390e1a21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Royal Oak IBFD Implant System |
| Version Model Number | TL251012-0001 |
| 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 | false |
| 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 |
| Phone | 248-853-1450 |
| customerservice@royaloakmed.com | |
| Phone | 248-853-1450 |
| customerservice@royaloakmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812352020885 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00812352020885]
Moist Heat or Steam Sterilization
[00812352020885]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2015-09-22 |
| 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 |