ROI-A
GUDID 03662663012751
ROI-A OBLIQUE IMPLANT 30X33 H16 10°
LDR Spine Usa, Inc.
Polymeric spinal fusion cage, sterile| Primary Device ID | 03662663012751 |
| NIH Device Record Key | 42891440-dafc-4f41-bb30-fb1d904fae5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROI-A |
| Version Model Number | IR4336P |
| Company DUNS | 615789729 |
| Company Name | LDR Spine Usa, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| 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
Device Dimensions
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 10 degree |
| Width | 33 Millimeter |
| Depth | 30 Millimeter |
| Height | 16 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663012751 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110327
FDA Product Code
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-03-10 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [ROI-A]
| 03662663041782 | ROI-A REMOVAL DEVICE |
| 03662663047050 | ROI-A Simplified Implant Holder |
| 03662663047005 | ROI-A RADD Retention Rod |
| 03662663046992 | ROI-A RADD Implant Holder Shaft |
| 03662663046930 | ROI-A Cage Holder with Impaction Lines |
| 03662663046923 | ROI-A Minimal Holder |
| 03662663043090 | IR9433R |
| 03662663041768 | ROI-A MEDIAN IMPLANT HOLDER |
| 03662663041683 | ANCHORING PLATE HOLDER |
| 03662663046190 | IR992 |
| 03662663024365 | IR997 |
| 03662663047067 | ROI-A Awl Impactor with Impaction Lines |
| 03662663047043 | ROI-A Starter Trial |
| 03662663047036 | ROI-A RADD Plate Impactor - Short |
| 03662663047029 | ROI-A RADD Plate Impactor - Long |
| 03662663047012 | ROI-A RADD Impaction Handle |
| 03662663046985 | ROI-A RADD Distractor Blade Split |
| 03662663046978 | ROI-A RADD Distractor Blade Solid |
| 03662663046961 | ROI-A RADD Distractor Body |
| 03662663046954 | ROI-A Long Impactor with Impaction Lines |
| 03662663046947 | ROI-A Short Impactor with Impaction Lines |
| 03662663043113 | ROI-A ADJUSTABLE STOP |
| 03662663043106 | IR9434R |
| 03662663043083 | IR9432R |
| 03662663043076 | IR9431R |
| 03662663043069 | IR9430R |
| 03662663043021 | IR9409R |
| 03662663043007 | IR9407R |
| 03662663042994 | IR9405R |
| 03662663042987 | ROI-A TRIAL 33X36 H19 14° |
| 03662663042970 | ROI-A TRIAL 33X36 H18 14° |
| 03662663042963 | ROI-A TRIAL 33X36 H17 14° |
| 03662663042956 | ROI-A TRIAL 33X36 H16 14° |
| 03662663042949 | ROI-A TRIAL 33X36 H15 14° |
| 03662663042925 | ROI-A TRIAL 33X36 H14 14° |
| 03662663042918 | ROI-A TRIAL 33X36 H19 10° |
| 03662663042901 | ROI-A TRIAL 33X36 H18 10° |
| 03662663042895 | ROI-A TRIAL 33X36 H17 10° |
| 03662663042888 | ROI-A TRIAL 33X36 H16 10° |
| 03662663042871 | ROI-A TRIAL 33X36 H15 10° |
| 03662663042864 | ROI-A TRIAL 33X36 H14 10° |
| 03662663042857 | ROI-A TRIAL 33X36 H13 10° |
| 03662663042840 | ROI-A TRIAL 33X36 H12 10° |
| 03662663042833 | ROI-A TRIAL 33X36 H17 6° |
| 03662663042819 | ROI-A TRIAL 33X36 H16 6° |
| 03662663042802 | ROI-A TRIAL 33X36 H15 6° |
| 03662663042796 | ROI-A TRIAL 33X36 H14 6° |
| 03662663042789 | ROI-A TRIAL 33X36 H13 6° |
| 03662663042772 | ROI-A TRIAL 33X36 H12 6° |
| 03662663042765 | ROI-A TRIAL 33X36 H11 6° |
Trademark Results [ROI-A]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROI-A 77288505 3573548 Live/Registered |
ZIMMER BIOMET SPINE, INC. 2007-09-25 |
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