The following data is part of a premarket notification filed by Titan Spine, Inc with the FDA for Endoskeleton Tas Plate.
| Device ID | K192054 |
| 510k Number | K192054 |
| Device Name: | Endoskeleton TAS Plate |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191375040125 | K192054 | 000 |
| 00191375040118 | K192054 | 000 |
| 00191375040101 | K192054 | 000 |
| 00191375039983 | K192054 | 000 |
| 00191375028987 | K192054 | 000 |
| 00191375028963 | K192054 | 000 |
| 00191375028239 | K192054 | 000 |
| 00191375028222 | K192054 | 000 |