Tranquil-C™
GUDID B6788222830
Cervical Trial 9x12x12 Convex
NEXUS SPINE, L.L.C.
Metallic spinal interbody fusion cage| Primary Device ID | B6788222830 |
| NIH Device Record Key | 5d9011e5-d49b-4b0b-a428-1b163085ab94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tranquil-C™ |
| Version Model Number | 822283 |
| Company DUNS | 028137605 |
| Company Name | NEXUS SPINE, L.L.C. |
| 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 |
Device Dimensions
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
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| Length | 12 Millimeter |
| Height | 9 Millimeter |
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| Height | 9 Millimeter |
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| Height | 9 Millimeter |
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| Height | 9 Millimeter |
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| Height | 9 Millimeter |
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| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
| Width | 12 Millimeter |
| Length | 12 Millimeter |
| Height | 9 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B678822283 [Direct Marking] |
| HIBCC | B6788222830 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170297
FDA Product Code
| HWT | Template |
| LXH | Orthopedic Manual Surgical Instrument |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B6788222830]
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[B6788222830]
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Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
On-Brand Devices [Tranquil-C™]
| B6788230480 | Stable-C Inserter |
| B6788227110 | Cervical Rasp, Thin Shaft, 10x18x14, 6 deg |
| B6788227100 | Cervical Rasp, Thin Shaft, 9x18x14, 6 deg |
| B6788227090 | Cervical Rasp, Thin Shaft, 8x18x14, 6 deg |
| B6788227080 | Cervical Rasp, Thin Shaft, 7x18x14, 6 deg |
| B6788227070 | Cervical Rasp, Thin Shaft, 6x18x14, 6 deg |
| B6788227060 | Cervical Rasp, Thin Shaft, 5x18x14, 6 deg |
| B6788227030 | Cervical Rasp, Thin Shaft, 10x16x13, 6 deg |
| B6788227020 | Cervical Rasp, Thin Shaft, 9x16x13, 6 deg |
| B6788227010 | Cervical Rasp, Thin Shaft, 8x16x13, 6 deg |
| B6788227000 | Cervical Rasp, Thin Shaft, 7x16x13, 6 deg |
| B6788226990 | Cervical Rasp, Thin Shaft, 6x16x13, 6 deg |
| B6788226980 | Cervical Rasp, Thin Shaft, 5x16x13, 6 deg |
| B6788226950 | Cervical Rasp, Thin Shaft, 10x14x12, 6 deg |
| B6788226940 | Cervical Rasp, Thin Shaft, 9x14x12, 6 deg |
| B6788226930 | Cervical Rasp, Thin Shaft, 8x14x12, 6 deg |
| B6788226920 | Cervical Rasp, Thin Shaft, 7x14x12, 6 deg |
| B6788226910 | Cervical Rasp, Thin Shaft, 6x14x12, 6 deg |
| B6788226900 | Cervical Rasp, Thin Shaft, 5x14x12, 6 deg |
| B6788226470 | Cervical Trial, Thin Shaft, 10x18x14, 6 deg |
| B6788226460 | Cervical Trial, Thin Shaft, 9x18x14, 6 deg |
| B6788226450 | Cervical Trial, Thin Shaft, 8x18x14, 6 deg |
| B6788226440 | Cervical Trial, Thin Shaft, 7x18x14, 6 deg |
| B6788226430 | Cervical Trial, Thin Shaft, 6x18x14, 6 deg |
| B6788226420 | Cervical Trial, Thin Shaft, 5x18x14, 6 deg |
| B6788226390 | Cervical Trial, Thin Shaft, 10x16x13, 6 deg |
| B6788226380 | Cervical Trial, Thin Shaft, 9x16x13, 6 deg |
| B6788226370 | Cervical Trial, Thin Shaft, 8x16x13, 6 deg |
| B6788226360 | Cervical Trial, Thin Shaft, 7x16x13, 6 deg |
| B6788226350 | Cervical Trial, Thin Shaft, 6x16x13, 6 deg |
| B6788226340 | Cervical Trial, Thin Shaft, 5x16x13, 6 deg |
| B6788226310 | Cervical Trial, Thin Shaft, 10x14x12, 6 deg |
| B6788226300 | Cervical Trial, Thin Shaft, 9x14x12, 6 deg |
| B6788226290 | Cervical Trial, Thin Shaft, 8x14x12, 6 deg |
| B6788226280 | Cervical Trial, Thin Shaft, 7x14x12, 6 deg |
| B6788226270 | Cervical Trial, Thin Shaft, 6x14x12, 6 deg |
| B6788226260 | Cervical Trial, Thin Shaft, 5x14x12, 6 deg |
| B6788225470 | Cervical Rasp 12x18x14, 12 deg Lordotic |
| B6788225460 | Cervical Rasp 11x18x14, 12 deg Lordotic |
| B6788225450 | Cervical Rasp 10x18x14, 12 deg Lordotic |
| B6788225440 | Cervical Rasp 9x18x14, 12 deg Lordotic |
| B6788225430 | Cervical Rasp 8x18x14, 12 deg Lordotic |
| B6788225420 | Cervical Rasp 7x18x14, 12 deg Lordotic |
| B6788225410 | Cervical Rasp 6x18x14, 12 deg Lordotic |
| B6788225400 | Cervical Rasp 5x18x14, 12 deg Lordotic |
| B6788225390 | Cervical Rasp 12x16x13, 12 deg Lordotic |
| B6788225380 | Cervical Rasp 11x16x13, 12 deg Lordotic |
| B6788225370 | Cervical Rasp 10x16x13, 12 deg Lordotic |
| B6788225360 | Cervical Rasp 9x16x13, 12 deg Lordotic |
| B6788225350 | Cervical Rasp 8x16x13, 12 deg Lordotic |
Trademark Results [Tranquil-C]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRANQUIL-C 88116186 not registered Live/Pending |
Nexus Spine, L.L.C. 2018-09-13 |
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