The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Arena-c Cervical Intervertebral Body Fusion System.
| Device ID | K113518 |
| 510k Number | K113518 |
| Device Name: | ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915 |
| Contact | Christopher Chang |
| Correspondent | Christopher Chang SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-29 |
| Decision Date | 2012-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190361036647 | K113518 | 000 |
| 00190361021056 | K113518 | 000 |
| 00190361021049 | K113518 | 000 |
| 00190361021032 | K113518 | 000 |
| 00190361021025 | K113518 | 000 |
| 00190361021018 | K113518 | 000 |
| 00190361021001 | K113518 | 000 |
| 00190361020998 | K113518 | 000 |
| 00190361020981 | K113518 | 000 |
| 00190361020974 | K113518 | 000 |
| 00190361020967 | K113518 | 000 |
| 00190361000082 | K113518 | 000 |
| 00190361000075 | K113518 | 000 |
| 00190361000068 | K113518 | 000 |
| 00190361000051 | K113518 | 000 |
| 00190361021063 | K113518 | 000 |
| 00190361036333 | K113518 | 000 |
| 00190361036630 | K113518 | 000 |
| 00190361036623 | K113518 | 000 |
| 00190361036616 | K113518 | 000 |
| 00190361036609 | K113518 | 000 |
| 00190361036593 | K113518 | 000 |
| 00190361036586 | K113518 | 000 |
| 00190361036579 | K113518 | 000 |
| 00190361036401 | K113518 | 000 |
| 00190361036395 | K113518 | 000 |
| 00190361036388 | K113518 | 000 |
| 00190361036371 | K113518 | 000 |
| 00190361036364 | K113518 | 000 |
| 00190361036357 | K113518 | 000 |
| 00190361036340 | K113518 | 000 |
| 00190361000044 | K113518 | 000 |