The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Vbs System.
Device ID | K081383 |
510k Number | K081383 |
Device Name: | RELIANCE VBS SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy, UT 84092 -7116 |
Contact | Bret M Berry |
Correspondent | Bret M Berry Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy, UT 84092 -7116 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-16 |
Decision Date | 2008-07-02 |
Summary: | summary |