ROI-A IR8307R
GUDID 03662663038867
ROI-A TRIAL 33X42 H10 2°
LDR Spine Usa, Inc.
Spinal implant trial| Primary Device ID | 03662663038867 |
| NIH Device Record Key | f315828d-98d1-4660-9956-f6af28d0a660 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROI-A |
| Version Model Number | IR8307R |
| Catalog Number | IR8307R |
| Company DUNS | 615789729 |
| Company Name | LDR Spine Usa, Inc. |
| 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 | false |
| 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 | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com |
Device Dimensions
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
| Angle | 2 degree |
| Height | 10 Millimeter |
| Width | 42 Millimeter |
| Depth | 33 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663038867 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153495
FDA Product Code
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
[03662663038867]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-03-10 |
| Device Publish Date | 2017-03-23 |
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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