The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Inc. with the FDA for Precice® Bone Transport™ System.
Device ID | K182170 |
510k Number | K182170 |
Device Name: | PRECICE® BONE TRANSPORT™ System |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
Contact | Vidhi Bhatt |
Correspondent | Vidhi Bhatt NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-10 |
Decision Date | 2019-02-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRECICE 97287304 not registered Live/Pending |
PRECICE MOTORSPORTS LLC 2022-02-28 |
PRECICE 88073801 not registered Live/Pending |
Epic Ice, LLC 2018-08-10 |
PRECICE 85064864 4158334 Live/Registered |
NUVASIVE, INC. 2010-06-16 |
PRECICE 76250632 not registered Dead/Abandoned |
KLA-Tencor Corporation 2001-05-03 |
PRECICE 75092861 not registered Dead/Abandoned |
Cadence Design Systems, Inc. 1996-04-23 |
PRECICE 75072688 not registered Dead/Abandoned |
BIODEX MEDICAL SYSTEMS, INC. 1996-03-14 |