The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for Visualif Challenging Access Plate.
| Device ID | K122168 |
| 510k Number | K122168 |
| Device Name: | VISUALIF CHALLENGING ACCESS PLATE |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin, TX 78701 |
| Contact | Clifton Naivar |
| Correspondent | Clifton Naivar SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin, TX 78701 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2012-10-11 |
| Summary: | summary |