The following data is part of a premarket notification filed by Transcorp, Inc. with the FDA for Transcorp Spinal Access System.
| Device ID | K113352 |
| 510k Number | K113352 |
| Device Name: | TRANSCORP SPINAL ACCESS SYSTEM |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2012-04-16 |
| Summary: | summary |