Stable-C™
GUDID B6785235270
Stable-C Interbody, 8x18x16mm, 6 deg
NEXUS SPINE, L.L.C.
Metallic spinal interbody fusion cage| Primary Device ID | B6785235270 |
| NIH Device Record Key | 1ecb7868-c176-4871-ae35-5f1db564ded6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stable-C™ |
| Version Model Number | 523527 |
| 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 | true |
| 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 | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
| Width | 18 Millimeter |
| Length | 16 Millimeter |
| Height | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B6785235270 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241467
FDA Product Code
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
[B6785235270]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-08 |
| Device Publish Date | 2024-09-30 |
On-Brand Devices [Stable-C™]
| B6785233280 | Cervical IBD 12x20x15, Planar, 12 Deg, Anchors |
| B6785233270 | Cervical IBD 11x20x15, Planar, 12 Deg, Anchors |
| B6785233260 | Cervical IBD 10x20x15, Planar, 12 Deg, Anchors |
| B6785233250 | Cervical IBD 9x20x15, Planar, 12 Deg, Anchors |
| B6785233240 | Cervical IBD 8x20x15, Planar, 12 Deg, Anchors |
| B6785233230 | Cervical IBD 7x20x15, Planar, 12 Deg, Anchors |
| B6785233220 | Cervical IBD 6x20x15, Planar, 12 Deg, Anchors |
| B6785233210 | Cervical IBD 5x20x15, Planar, 12 Deg, Anchors |
| B6785233200 | Cervical IBD 12x20x15, Planar, 6 Deg, Anchors |
| B6785233190 | Cervical IBD 11x20x15, Planar, 6 Deg, Anchors |
| B6785233180 | Cervical IBD 10x20x15, Planar, 6 Deg, Anchors |
| B6785233170 | Cervical IBD 9x20x15, Planar, 6 Deg, Anchors |
| B6785233160 | Cervical IBD 8x20x15, Planar, 6 Deg, Anchors |
| B6785233150 | Cervical IBD 7x20x15, Planar, 6 Deg, Anchors |
| B6785233140 | Cervical IBD 6x20x15, Planar, 6 Deg, Anchors |
| B6785233130 | Cervical IBD 5x20x15, Planar, 6 Deg, Anchors |
| B6785233120 | Cervical IBD 12x20x15, Planar, 0 Deg, Anchors |
| B6785233110 | Cervical IBD 11x20x15, Planar, 0 Deg, Anchors |
| B6785233100 | Cervical IBD 10x20x15, Planar, 0 Deg, Anchors |
| B6785233090 | Cervical IBD 9x20x15, Planar, 0 Deg, Anchors |
| B6785233080 | Cervical IBD 8x20x15, Planar, 0 Deg, Anchors |
| B6785233070 | Cervical IBD 7x20x15, Planar, 0 Deg, Anchors |
| B6785233060 | Cervical IBD 6x20x15, Planar, 0 Deg, Anchors |
| B6785233050 | Cervical IBD 5x20x15, Planar, 0 Deg, Anchors |
| B6785231040 | Cervical IBD 12x18x14, Planar, 0 Deg, Anchors |
| B6785231030 | Cervical IBD 11x18x14, Planar, 0 Deg, Anchors |
| B6785231020 | Cervical IBD 10x18x14, Planar, 0 Deg, Anchors |
| B6785231010 | Cervical IBD 9x18x14, Planar, 0 Deg, Anchors |
| B6785231000 | Cervical IBD 8x18x14, Planar, 0 Deg, Anchors |
| B6785230990 | Cervical IBD 7x18x14, Planar, 0 Deg, Anchors |
| B6785230980 | Cervical IBD 6x18x14, Planar, 0 Deg, Anchors |
| B6785230970 | Cervical IBD 5x18x14, Planar, 0 Deg, Anchors |
| B6785230960 | Cervical IBD 12x16x13, Planar, 0 Deg, Anchors |
| B6785230950 | Cervical IBD 11x16x13, Planar, 0 Deg, Anchors |
| B6785230940 | Cervical IBD 10x16x13, Planar, 0 Deg, Anchors |
| B6785230930 | Cervical IBD 9x16x13, Planar, 0 Deg, Anchors |
| B6785230920 | Cervical IBD 8x16x13, Planar, 0 Deg, Anchors |
| B6785230910 | Cervical IBD 7x16x13, Planar, 0 Deg, Anchors |
| B6785230900 | Cervical IBD 6x16x13, Planar, 0 Deg, Anchors |
| B6785230890 | Cervical IBD 5x16x13, Planar, 0 Deg, Anchors |
| B6785230880 | Cervical IBD 12x14x12, Planar, 0 Deg, Anchors |
| B6785230870 | Cervical IBD 11x14x12, Planar, 0 Deg, Anchors |
| B6785230860 | Cervical IBD 10x14x12, Planar, 0 Deg, Anchors |
| B6785230850 | Cervical IBD 9x14x12, Planar, 0 Deg, Anchors |
| B6785230840 | Cervical IBD 8x14x12, Planar, 0 Deg, Anchors |
| B6785230830 | Cervical IBD 7x14x12, Planar, 0 Deg, Anchors |
| B6785230820 | Cervical IBD 6x14x12, Planar, 0 Deg, Anchors |
| B6785230810 | Cervical IBD 5x14x12, Planar, 0 Deg, Anchors |
| B6785230720 | Cervical IBD 12x18x14, Planar, 18 Deg, Anchors |
| B6785230710 | Cervical IBD 11x18x14, Planar, 18 Deg, Anchors |
Trademark Results [Stable-C]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STABLE-C 88704390 not registered Live/Pending |
Nexus Spine, L.L.C. 2019-11-23 |
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