The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for In:c2 Spinal Fixation System.
| Device ID | K122630 |
| 510k Number | K122630 |
| Device Name: | IN:C2 SPINAL FIXATION SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin, TX 78701 |
| Contact | Clifton (chris) Naivar |
| Correspondent | Clifton (chris) Naivar SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin, TX 78701 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-28 |
| Decision Date | 2012-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817771029822 | K122630 | 000 |
| 00817771029815 | K122630 | 000 |
| 00817771027637 | K122630 | 000 |