ROI-C MC9114R
GUDID 03662663043847
ROI-C LORDOTIC MONOBLOCK TRIAL 14x14 H7
LDR Spine Usa, Inc.
Spinal implant trial| Primary Device ID | 03662663043847 |
| NIH Device Record Key | efbfde2f-0b94-44df-9163-01bf3104eb64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROI-C |
| Version Model Number | MC9114R |
| Catalog Number | MC9114R |
| 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 |
Device Dimensions
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
| Height | 7 Millimeter |
| Width | 14 Millimeter |
| Depth | 14 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663043847 [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 |
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
Moist Heat or Steam Sterilization
[03662663043847]
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 | 2017-03-24 |
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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