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 | K101085 |
| 510k Number | K101085 |
| Device Name: | SPINESMITH CYNCH SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINE SMITH PARTNERS L.P. 5300 NORTH LAMAR BLVD #107 Austin, TX 78751 |
| Contact | Laura Leboeuf |
| Correspondent | Laura Leboeuf SPINE SMITH PARTNERS L.P. 5300 NORTH LAMAR BLVD #107 Austin, TX 78751 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2010-07-01 |
| Summary: | summary |