The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for Spinesmith Cimplicity Spinal System.
Device ID | K080971 |
510k Number | K080971 |
Device Name: | SPINESMITH CIMPLICITY SPINAL SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | SPINE SMITH PARTNERS L.P. 8140 N. MOPAC BLDG II, SUITE 120 Austin, TX 78759 |
Contact | Robert Jones |
Correspondent | Robert Jones SPINE SMITH PARTNERS L.P. 8140 N. MOPAC BLDG II, SUITE 120 Austin, TX 78759 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-04 |
Decision Date | 2008-07-02 |
Summary: | summary |