The following data is part of a premarket notification filed by Spinesmith Holdings, Llc with the FDA for In:c2 Spinal Fixation Systme.
| Device ID | K141537 |
| 510k Number | K141537 |
| Device Name: | IN:C2 SPINAL FIXATION SYSTME |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SPINESMITH HOLDINGS, LLC 93 RED RIVER Austin, TX 78701 |
| Contact | Clifton (chris) Naivar |
| Correspondent | Clifton (chris) Naivar SPINESMITH HOLDINGS, LLC 93 RED RIVER Austin, TX 78701 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-10 |
| Decision Date | 2014-11-25 |
| Summary: | summary |