SpineNet SSP® 106-01
GUDID B047106010
SpineNet SSP® Bone Awl-Instrument
SPINENET, LLC
General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit| Primary Device ID | B047106010 |
| NIH Device Record Key | 8e2ac5f7-9a4f-476b-83bf-5da064680678 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpineNet SSP® |
| Version Model Number | SpineNet SSP® Bone Awl |
| Catalog Number | 106-01 |
| 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 | 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 | 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 | B047106010 [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 |
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
[B047106010]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-20 |
| Device Publish Date | 2022-01-12 |
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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