The following data is part of a premarket notification filed by Royal Oak Medical Devices with the FDA for Helena System.
| Device ID | K110177 |
| 510k Number | K110177 |
| Device Name: | HELENA SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ROYAL OAK MEDICAL DEVICES 39533 WOODWARD AVENUE Bloomfield Hills, MI 48304 |
| Contact | Matthew Kroll |
| Correspondent | Matthew Kroll ROYAL OAK MEDICAL DEVICES 39533 WOODWARD AVENUE Bloomfield Hills, MI 48304 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-21 |
| Decision Date | 2011-04-21 |
| Summary: | summary |