The following data is part of a premarket notification filed by Titan Spine, Llc with the FDA for Endoskeleton To Interbody Fusion Device (ibd).
| Device ID | K170399 |
| 510k Number | K170399 |
| Device Name: | Endoskeleton TO Interbody Fusion Device (IBD) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Titan Spine, LLC 6140 W. Executive Dr., Suite A Mequon, WI 53092 |
| Contact | Jane Rodd |
| Correspondent | Christine Scifert MRC/X, LLC 6075 Poplar Ave. Memphis, TN 38119 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-09 |
| Decision Date | 2017-07-06 |
| Summary: | summary |