The following data is part of a premarket notification filed by Rti Surgical, Inc. Dba Rti Biologics with the FDA for Interbody Fusion (ibf)/vertebral Body Replacement(vbr) System.
| Device ID | K150521 |
| 510k Number | K150521 |
| Device Name: | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | RTI SURGICAL, INC. Dba RTI BIOLOGICS 11621 Research Cir Alachua, FL 32615 |
| Contact | Jennifer Bonacci |
| Correspondent | Jennifer Bonacci RTI SURGICAL, INC. Dba RTI BIOLOGICS 11621 Research Cir Alachua, FL 32615 |
| Product Code | ODP |
| Subsequent Product Code | MAX |
| Subsequent Product Code | MQP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468086664 | K150521 | 000 |