Ni-Lock® Anterior Cervical Plate System 15-R412
GUDID 10840642103847
Screw Fixed Self-Drilling 4.0mm x 12mm
Spine Wave, Inc.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 10840642103847 |
| NIH Device Record Key | c7773d3f-1fcf-4074-a0d7-db1dedc568fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ni-Lock® Anterior Cervical Plate System |
| Version Model Number | 15-R412 |
| Catalog Number | 15-R412 |
| Company DUNS | 067789763 |
| Company Name | Spine Wave, 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 | 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 |
Customer Support Contacts
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com |
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840642103847 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091926
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
[10840642103847]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-12 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [Ni-Lock® Anterior Cervical Plate System]
| 10840642103076 | Plate 50mm 3 Level |
| 10840642103069 | Plate 48mm 3 Level |
| 10840642103052 | Plate 44mm 3 Level |
| 10840642103045 | Plate 40mm 3 Level |
| 10840642103038 | Plate 44mm 2 Level |
| 10840642103021 | Plate 40mm 2 Level |
| 10840642103014 | Plate 36mm 2 Level |
| 10840642103007 | Plate 34mm 2 Level |
| 10840642102994 | Plate 32mm 2 Level |
| 10840642102987 | Plate 30mm 2 Level |
| 10840642103250 | Plate 84mm 4 Level |
| 10840642103243 | Plate 80mm 4 Level |
| 10840642103236 | Plate 76mm 4 Level |
| 10840642103229 | Plate 72mm 4 Level |
| 10840642103212 | Plate 68mm 4 Level |
| 10840642103205 | Plate 64mm 4 Level |
| 10840642103199 | Plate 60mm 4 Level |
| 10840642103106 | Plate 62mm 3 Level |
| 10840642103090 | Plate 58mm 3 Level |
| 10840642103083 | Plate 54mm 3 Level |
| 10840642102970 | Plate 28mm 2 Level |
| 10840642102963 | Plate 26mm 2 Level |
| 10840642102956 | Plate 24mm 2 Level |
| 10840642102949 | Plate 22mm 2 Level |
| 10840642102932 | Plate 20mm 2 Level |
| 10840642102925 | Plate 26mm 1 Level |
| 10840642102918 | Plate 24mm 1 Level |
| 10840642102901 | Plate 22mm 1 Level |
| 10840642102895 | Plate 20mm 1 Level |
| 10840642102888 | Plate 18mm 1 Level |
| 10840642102871 | Plate 16mm 1 Level |
| 10840642103885 | Screw Fixed Self-Drilling 4.0mm x 20mm |
| 10840642103878 | Screw Fixed Self-Drilling 4.0mm x 18mm |
| 10840642103861 | Screw Fixed Self-Drilling 4.0mm x 16mm |
| 10840642103854 | Screw Fixed Self-Drilling 4.0mm x 14mm |
| 10840642103847 | Screw Fixed Self-Drilling 4.0mm x 12mm |
| 10840642103830 | Screw Fixed Self-Drilling 4.0mm x 10mm |
| 10840642103823 | Screw Variable Self-Drilling 4.0mm x 20mm |
| 10840642103816 | Screw Variable Self-Drilling 4.0mm x 18mm |
| 10840642103809 | Screw Variable Self-Drilling 4.0mm x 16mm |
| 10840642103793 | Screw Variable Self-Drilling 4.0mm x 14mm |
| 10840642103786 | Screw Variable Self-Drilling 4.0mm x 12mm |
| 10840642103779 | Screw Variable Self-Drilling 4.0mm x 10mm |
| 10840642103762 | Screw Fixed Self-Tapping 4.5mm x 20mm |
| 10840642103755 | Screw Fixed Self-Tapping 4.5mm x 18mm |
| 10840642103748 | Screw Fixed Self-Tapping 4.5mm x 16mm |
| 10840642103731 | Screw Fixed Self-Tapping 4.5mm x 14mm |
| 10840642103724 | Screw Fixed Self-Tapping 4.5mm x 12mm |
| 10840642103717 | Screw Fixed Self-Tapping 4.5mm x 10mm |
| 10840642103700 | Screw Variable Self-Tapping 4.5mm x 20mm |
Trademark Results [Ni-Lock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NI-LOCK 85513578 4239245 Live/Registered |
Spine Wave, Inc. 2012-01-11 |
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