The following data is part of a premarket notification filed by Vallum Corporation with the FDA for Peekplus® Interbody Fusion Device.
Device ID | K173864 |
510k Number | K173864 |
Device Name: | Peekplus® Interbody Fusion Device |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Vallum Corporation 61 Spit Brook Road Nashua, NH 03060 |
Contact | Stephen Blinn |
Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-20 |
Decision Date | 2018-07-02 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PEEKPLUS 86825976 5120863 Live/Registered |
Vallum Corporation 2015-11-19 |
![]() PEEKPLUS 76069289 not registered Dead/Abandoned |
BYTWARE, Inc. 2000-06-13 |