Proficient™ Posterior Cervical Spine System 11-8114
GUDID 10840642113075
Extended Tab Screw, 3.8 mm x 48 mm
Spine Wave, Inc.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 10840642113075 |
| NIH Device Record Key | 79a10f6c-169d-4113-bdf3-8d8a2768b21d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Proficient™ Posterior Cervical Spine System |
| Version Model Number | 11-8114 |
| Catalog Number | 11-8114 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840642113075 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162639
FDA Product Code
| NKG | Orthosis, Cervical Pedicle Screw Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
[10840642113075]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-06-06 |
| Device Publish Date | 2017-04-28 |
On-Brand Devices [Proficient™ Posterior Cervical Spine System]
| 10840642113051 | Extended Tab Screw, 3.8 mm x 45 mm |
| 10840642113044 | Extended Tab Screw, 3.8 mm x 44 mm |
| 10840642113037 | Extended Tab Screw, 3.8 mm x 42 mm |
| 10840642113020 | Extended Tab Screw, 3.8 mm x 40 mm |
| 10840642113013 | Extended Tab Screw, 3.8 mm x 38 mm |
| 10840642113006 | Extended Tab Screw, 3.8 mm x 36 mm |
| 10840642112993 | Extended Tab Screw, 3.8 mm x 8 mm |
| 10840642112986 | Screw, 5.5 mm x 50 mm |
| 10840642112979 | Screw, 5.5 mm x 48 mm |
| 10840642112962 | Screw, 5.5 mm x 46 mm |
| 10840642112955 | Screw, 5.5 mm x 45 mm |
| 10840642112948 | Screw, 5.5 mm x 44 mm |
| 10840642112931 | Screw, 5.5 mm x 42 mm |
| 10840642112924 | Screw, 5.5 mm x 38 mm |
| 10840642112917 | Screw, 5.5 mm x 34 mm |
| 10840642112900 | Screw, 5.5 mm x 30 mm |
| 10840642112894 | Screw, 5.5 mm x 26 mm |
| 10840642112887 | Screw, 5.5 mm x 22 mm |
| 10840642112870 | Screw, 4.6 mm x 50 mm |
| 10840642112863 | Screw, 4.6 mm x 48 mm |
| 10840642112856 | Screw, 4.6 mm x 46 mm |
| 10840642112849 | Screw, 4.6 mm x 45 mm |
| 10840642112832 | Screw, 4.6 mm x 44 mm |
| 10840642112825 | Screw, 4.6 mm x 42 mm |
| 10840642112818 | Screw, 4.6 mm x 38 mm |
| 10840642112801 | Screw, 4.6 mm x 34 mm |
| 10840642112795 | Screw, 4.6 mm x 30 mm |
| 10840642112788 | Screw, 4.6 mm x 26 mm |
| 10840642112771 | Screw, 4.6 mm x 22 mm |
| 10840642112764 | Screw, 4.2 mm x 50 mm |
| 10840642112757 | Screw, 4.2 mm x 48 mm |
| 10840642112740 | Screw, 4.2 mm x 46 mm |
| 10840642112733 | Screw, 4.2 mm x 45 mm |
| 10840642112726 | Screw, 4.2 mm x 44 mm |
| 10840642112719 | Screw, 4.2 mm x 42 mm |
| 10840642112702 | Screw, 4.2 mm x 40 mm |
| 10840642112696 | Screw, 4.2 mm x 38 mm |
| 10840642112689 | Screw, 4.2 mm x 36 mm |
| 10840642112672 | Screw, 4.2 mm x 8 mm |
| 10840642112665 | Screw, 3.8 mm x 50 mm |
| 10840642112658 | Screw, 3.8 mm x 48 mm |
| 10840642112641 | Screw, 3.8 mm x 46 mm |
| 10840642112634 | Screw, 3.8 mm x 45 mm |
| 10840642112627 | Screw, 3.8 mm x 44 mm |
| 10840642112610 | Screw, 3.8 mm x 42 mm |
| 10840642112603 | Screw, 3.8 mm x 40 mm |
| 10840642112597 | Screw, 3.8 mm x 38 mm |
| 10840642112580 | Screw, 3.8 mm x 36 mm |
| 10840642112573 | Screw, 3.8 mm x 8 mm |
| 10840642109917 | Extended Tab Screw, 3.8 mm x 34 mm |
Trademark Results [Proficient]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFICIENT 86251018 5228450 Live/Registered |
Spine Wave, Inc. 2014-04-14 |
 PROFICIENT 85484787 4227656 Dead/Cancelled |
Wahl Clipper Corporation 2011-12-01 |
 PROFICIENT 78081001 not registered Dead/Abandoned |
Kelly, Sean, J. 2001-08-24 |
 PROFICIENT 77206013 3689861 Dead/Cancelled |
Speakercraft, Inc. 2007-06-14 |
 PROFICIENT 77205984 3689860 Live/Registered |
Core Brands, LLC 2007-06-14 |
 PROFICIENT 76362812 not registered Dead/Abandoned |
IBS Software Services (P) Limited 2002-01-25 |
 PROFICIENT 76331392 not registered Dead/Abandoned |
Proficient Systems, Inc. 2001-10-30 |
 PROFICIENT 75135598 2091016 Dead/Cancelled |
ADVANCED MEDICAL OPTICS, INC. 1996-07-17 |
 PROFICIENT 73786333 1565741 Dead/Cancelled |
BLOCK DRUG CORPORATION 1989-03-13 |
 PROFICIENT 73682379 1486811 Dead/Cancelled |
COMMUNICATION INTELLIGENCE CORPORATION 1987-09-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.