The following data is part of a premarket notification filed by Titan Spine, Llc with the FDA for Endoskeleton(r) Tcs System.
| Device ID | K153122 |
| 510k Number | K153122 |
| Device Name: | Endoskeleton(r) TCS System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | TITAN SPINE, LLC 6140 W. EXECUTIVE DRIVE, SUITE A Mequon, WI 53092 |
| Contact | Jane Rodd |
| Correspondent | Christine Scifert Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-29 |
| Decision Date | 2015-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191375018599 | K153122 | 000 |
| 00191375018506 | K153122 | 000 |
| 00191375018513 | K153122 | 000 |
| 00191375018520 | K153122 | 000 |
| 00191375018537 | K153122 | 000 |
| 00191375018544 | K153122 | 000 |
| 00191375018551 | K153122 | 000 |
| 00191375018568 | K153122 | 000 |
| 00191375018575 | K153122 | 000 |
| 00191375018582 | K153122 | 000 |
| 00191375018490 | K153122 | 000 |