The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Proficient® Posterior Cervical Spine System.
Device ID | K181440 |
510k Number | K181440 |
Device Name: | Proficient® Posterior Cervical Spine System |
Classification | Posterior Cervical Screw System |
Applicant | Spine Wave, Inc. 3 Enterprise Drive, Suite 210 Shelton, CT 06484 |
Contact | Amy Noccioli |
Correspondent | Amy Noccioli Spine Wave, Inc. 3 Enterprise Drive, Suite 210 Shelton, CT 06484 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-01 |
Decision Date | 2018-07-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10840642160765 | K181440 | 000 |
10840642131376 | K181440 | 000 |
10840642131352 | K181440 | 000 |
10840642131338 | K181440 | 000 |
10840642131314 | K181440 | 000 |
10840642131291 | K181440 | 000 |
10840642131277 | K181440 | 000 |
10840642131253 | K181440 | 000 |
10840642130850 | K181440 | 000 |
10840642130737 | K181440 | 000 |
10840642130676 | K181440 | 000 |
10840642130614 | K181440 | 000 |
10840642130553 | K181440 | 000 |
10840642131390 | K181440 | 000 |
10840642131413 | K181440 | 000 |
10840642132281 | K181440 | 000 |
10840642131628 | K181440 | 000 |
10840642131604 | K181440 | 000 |
10840642131581 | K181440 | 000 |
10840642131567 | K181440 | 000 |
10840642131543 | K181440 | 000 |
10840642131529 | K181440 | 000 |
10840642131505 | K181440 | 000 |
10840642131482 | K181440 | 000 |
10840642131468 | K181440 | 000 |
10840642131444 | K181440 | 000 |
10840642131437 | K181440 | 000 |
10840642130300 | K181440 | 000 |
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 |