The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Spine Spacer System.
| Device ID | K131292 |
| 510k Number | K131292 |
| Device Name: | DEROYAL SPINE SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DEROYAL INDUSTRIES, INC. PO BOX 566 Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden, Phd |
| Correspondent | Karen E Warden, Phd DEROYAL INDUSTRIES, INC. PO BOX 566 Chesterland, OH 44026 -2141 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2014-02-03 |
| Summary: | summary |