The following data is part of a premarket notification filed by Pioneer Surgical Technology,inc. Dba Rti Surgical, Inc. with the FDA for Unison-c Anterior Cervical Fixation System.
| Device ID | K152793 |
| 510k Number | K152793 |
| Device Name: | Unison-C Anterior Cervical Fixation System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | PIONEER SURGICAL TECHNOLOGY,INC. DBA RTI SURGICAL, INC. 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Emily Roberge |
| Correspondent | Kenneth C Maxwell Ii Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-01-19 |
| Summary: | summary |