SpineNet SSP® 2-4835
GUDID B047248350
SpineNet SSP®, Plate, 2-Level, 48mm
SPINENET, LLC
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | B047248350 |
| NIH Device Record Key | dc6bf619-16c9-4b8b-a808-f0df55c36674 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpineNet SSP® |
| Version Model Number | SSP® Plate |
| Catalog Number | 2-4835 |
| Company DUNS | 792052321 |
| Company Name | SPINENET, LLC |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com | |
| Phone | 407-539-2483 |
| info@spinenetllc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B047248350 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200170
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
[B047248350]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2021-12-14 |
On-Brand Devices [SpineNet SSP®]
| B047FB46140 | SpineNet SSP®, Fixed Screw, Blunt, 4.65x14mm |
| B047FB46120 | SpineNet SSP®, Fixed Screw, Blunt, 4.65x12mm |
| B047FB42140 | SpineNet SSP®, Fixed Screw, Blunt, 4.25x14mm |
| B047FB42120 | SpineNet SSP®, Fixed Screw, Blunt, 4.25x12mm |
| B047248350 | SpineNet SSP®, Plate, 2-Level, 48mm |
| B047245320 | SpineNet SSP®, Plate, 2-Level, 45mm |
| B047242290 | SpineNet SSP®, Plate, 2-Level, 42mm |
| B047126130 | SpineNet SSP®, Plate, 1 Level, 26mm |
| B047124110 | SpineNet SSP®, Plate, 1 Level, 24mm |
| B047106090 | SpineNet SSP®, Screw Driver-Instrument |
| B04710603180 | SpineNet SSP®, 18mm, Drill Sleeve-Instrument |
| B04710603160 | SpineNet SSP®, 16mm, Drill Sleeve-Instrument |
| B04710603140 | SpineNet SSP®, 14mm, Drill Sleeve-Instrument |
| B04710603120 | SpineNet SSP®, 12mm, Drill Sleeve-Instrument |
| B047106020 | SpineNet SSP® (Single Screw Plate) System, 2.4x18mm, Drill Bit-Instrument, |
| B047106120 | SpineNet SSP® Plate Bender- Instrument |
| B047106110 | SpineNet SSP® Cam Lock Driver-Instrument |
| B047106100 | SpineNet SSP® Cam Torque Limiter Handle-Instrument |
| B047106080 | SpineNet SSP®, Variable Drill Guide-Instrument |
| B047106070 | SpineNet SSP®, Fixed Drill Guide-Instrument |
| B047106060 | SpineNet SSP® Small AO Chuck Handle- Instrument |
| B047106040 | SpineNet SSP® , Bone Tap, 4.25x12mm-Instrument |
| B047106010 | SpineNet SSP® Bone Awl-Instrument |
Trademark Results [SpineNet SSP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPINENET SSP 87343735 not registered Live/Pending |
Spinenet, LLC 2017-02-21 |
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