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 |