The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for Spinesmith Cynch Spinal System.
| Device ID | K090376 |
| 510k Number | K090376 |
| Device Name: | SPINESMITH CYNCH SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-04-01 |
| Summary: | summary |