The following data is part of a premarket notification filed by Titan Spine, Inc with the FDA for Endoskeleton Tcs Interbody Fusion Device.
| Device ID | K191565 |
| 510k Number | K191565 |
| Device Name: | Endoskeleton TCS Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Titan Spine, Inc 6140 W. Executive Dr., Suite A Mequon, WI 53092 |
| Contact | Kelly Mcdonnell |
| Correspondent | Christine Scifert MRC/X, LLC 6075 Poplar Ave Memphis, TN 38119 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2019-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191375046608 | K191565 | 000 |
| 00191375046592 | K191565 | 000 |
| 00191375039976 | K191565 | 000 |
| 00191375030775 | K191565 | 000 |