ROI-C MC9016R
GUDID 03662663043267
ROI-C MONOBLOCK TRIAL 12X14 H10
LDR Spine Usa, Inc.
Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial| Primary Device ID | 03662663043267 |
| NIH Device Record Key | 3824f7aa-c122-4711-9f18-f747d4b5fe91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROI-C |
| Version Model Number | MC9016R |
| Catalog Number | MC9016R |
| 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 |
Device Dimensions
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
| Height | 10 Millimeter |
| Width | 14 Millimeter |
| Depth | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663043267 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151934
FDA Product Code
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
Moist Heat or Steam Sterilization
[03662663043267]
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-C]
| 03662663043625 | PLATE REMOVAL INSTRUMENT |
| 03662663045650 | ROI-C COATED IMPLANT 12x15.5 H10 |
| 03662663045643 | ROI-C COATED IMPLANT 12x15.5 H9 |
| 03662663045636 | ROI-C COATED IMPLANT 12x14 H10 |
| 03662663045629 | ROI-C COATED IMPLANT 12x14 H9 |
| 03662663045612 | ROI-C COATED IMPLANT 14x17 H10 |
| 03662663045605 | ROI-C COATED IMPLANT 14x17 H9 |
| 03662663045599 | ROI-C COATED IMPLANT 14x15.5 H10 |
| 03662663045582 | ROI-C COATED IMPLANT 14x15.5 H9 |
| 03662663045575 | ROI-C COATED IMPLANT 14x14 H10 |
| 03662663045568 | ROI-C COATED IMPLANT 14x14 H9 |
| 03662663023641 | ROI-C LORDOTIC COATED IMPLANT 12x15,5 H10 |
| 03662663023634 | ROI-C LORDOTIC COATED IMPLANT 12x15,5 H9 |
| 03662663023627 | ROI-C LORDOTIC COATED IMPLANT 12x15,5 H8 |
| 03662663023610 | ROI-C LORDOTIC COATED IMPLANT 12x15,5 H7 |
| 03662663023603 | ROI-C LORDOTIC COATED IMPLANT 12x15,5 H6 |
| 03662663023597 | ROI-C LORDOTIC COATED IMPLANT 12x15,5 H5 |
| 03662663023580 | ROI-C LORDOTIC COATED IMPLANT 12x14 H10 |
| 03662663023573 | ROI-C LORDOTIC COATED IMPLANT 12x14 H9 |
| 03662663023566 | ROI-C LORDOTIC COATED IMPLANT 12x14 H8 |
| 03662663023559 | ROI-C LORDOTIC COATED IMPLANT 12x14 H7 |
| 03662663023542 | ROI-C LORDOTIC COATED IMPLANT 12x14 H6 |
| 03662663023535 | ROI-C LORDOTIC COATED IMPLANT 12x14 H5 |
| 03662663023528 | ROI-C LORDOTIC COATED IMPLANT 14x17 H10 |
| 03662663023511 | ROI-C LORDOTIC COATED IMPLANT 14x17 H9 |
| 03662663023504 | ROI-C LORDOTIC COATED IMPLANT 14x17 H8 |
| 03662663023481 | ROI-C LORDOTIC COATED IMPLANT 14x17 H6 |
| 03662663023474 | ROI-C LORDOTIC COATED IMPLANT 14x17 H5 |
| 03662663023467 | ROI-C LORDOTIC COATED IMPLANT 14x15,5 H10 |
| 03662663023450 | ROI-C LORDOTIC COATED IMPLANT 14x15,5 H9 |
| 03662663023443 | ROI-C LORDOTIC COATED IMPLANT 14x15,5 H8 |
| 03662663023436 | ROI-C LORDOTIC COATED IMPLANT 14x15,5 H7 |
| 03662663023429 | ROI-C LORDOTIC COATED IMPLANT 14x15,5 H6 |
| 03662663023412 | ROI-C LORDOTIC COATED IMPLANT 14x15,5 H5 |
| 03662663023405 | ROI-C LORDOTIC COATED IMPLANT 14x14 H10 |
| 03662663023399 | ROI-C LORDOTIC COATED IMPLANT 14x14 H9 |
| 03662663023382 | ROI-C LORDOTIC COATED IMPLANT 14x14 H8 |
| 03662663023375 | ROI-C LORDOTIC COATED IMPLANT 14x14 H7 |
| 03662663023368 | ROI-C LORDOTIC COATED IMPLANT 14x14 H6 |
| 03662663023351 | ROI-C LORDOTIC COATED IMPLANT 14x14 H5 |
| 03662663023344 | ROI-C COATED IMPLANT 12x15,5 H8 |
| 03662663023337 | ROI-C COATED IMPLANT 12x15,5 H7 |
| 03662663023320 | ROI-C COATED IMPLANT 12x15,5 H6 |
| 03662663023313 | ROI-C COATED IMPLANT 12x15,5 H5 |
| 03662663023306 | ROI-C COATED IMPLANT 12x15,5 H4,5 |
| 03662663023290 | ROI-C COATED IMPLANT 12x14 H8 |
| 03662663023283 | ROI-C COATED IMPLANT 12x14 H7 |
| 03662663023276 | ROI-C COATED IMPLANT 12x14 H6 |
| 03662663023269 | ROI-C COATED IMPLANT 12x14 H5 |
| 03662663023252 | ROI-C COATED IMPLANT 12x14 H4,5 |
Trademark Results [ROI-C]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROI-C 77886510 3849660 Live/Registered |
ZIMMER BIOMET SPINE, INC. 2009-12-04 |
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