The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for Cimplicity Spinal System.
Device ID | K073320 |
510k Number | K073320 |
Device Name: | CIMPLICITY SPINAL SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | SPINE SMITH PARTNERS L.P. 5300 NORTH LAMAR BLVD #107 Austin, TX 78751 |
Contact | Robert Jones |
Correspondent | Robert Jones SPINE SMITH PARTNERS L.P. 5300 NORTH LAMAR BLVD #107 Austin, TX 78751 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-26 |
Decision Date | 2008-02-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817771020003 | K073320 | 000 |