The following data is part of a premarket notification filed by Transcorp, Inc. with the FDA for Transcorp Acif System.
| Device ID | K121178 |
| 510k Number | K121178 |
| Device Name: | TRANSCORP ACIF SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | TRANSCORP, INC. 1000 100TH ST. SW, SUITE F Byron Center, MI 49315 |
| Contact | Andrew Rodenhouse |
| Correspondent | Andrew Rodenhouse TRANSCORP, INC. 1000 100TH ST. SW, SUITE F Byron Center, MI 49315 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-18 |
| Decision Date | 2013-07-05 |
| Summary: | summary |