The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Modification To Staxx Fx System.
Device ID | K063606 |
510k Number | K063606 |
Device Name: | MODIFICATION TO STAXX FX SYSTEM |
Classification | Cement, Bone, Pre-formed, Modular, Polymeric, Vertebroplasty |
Applicant | SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 Shelton, CT 06484 |
Contact | Ronald K Smith |
Correspondent | Ronald K Smith SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 Shelton, CT 06484 |
Product Code | OBL |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-01 |
Decision Date | 2007-04-13 |
Summary: | summary |