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 |