The following data is part of a premarket notification filed by Titan Spine, Llc with the FDA for Endoskeleton(r) Tas Interbody Fusion Device / Endoskeleton(r) Tas Hyperlordotic Interbody Fusion Device.
| Device ID | K163269 |
| 510k Number | K163269 |
| Device Name: | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | TITAN SPINE, LLC 6140 W. EXECUTIVE DR STE A Mequon, WI 53092 |
| Contact | Jane Rodd |
| Correspondent | Christine Scifert MRC-X, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191375027737 | K163269 | 000 |
| 00191375025832 | K163269 | 000 |
| 00191375026532 | K163269 | 000 |
| 00191375026518 | K163269 | 000 |
| 00191375026495 | K163269 | 000 |
| 00191375026488 | K163269 | 000 |
| 00191375026464 | K163269 | 000 |
| 00191375026440 | K163269 | 000 |
| 00191375026426 | K163269 | 000 |
| 00191375026402 | K163269 | 000 |
| 00191375026389 | K163269 | 000 |
| 00191375026341 | K163269 | 000 |
| 00191375026303 | K163269 | 000 |
| 00191375026280 | K163269 | 000 |
| 00191375026273 | K163269 | 000 |
| 00191375026259 | K163269 | 000 |
| 00191375026235 | K163269 | 000 |
| 00191375025856 | K163269 | 000 |
| 00191375025870 | K163269 | 000 |
| 00191375025894 | K163269 | 000 |
| 00191375027720 | K163269 | 000 |
| 00191375026198 | K163269 | 000 |
| 00191375026174 | K163269 | 000 |
| 00191375026150 | K163269 | 000 |
| 00191375026136 | K163269 | 000 |
| 00191375026105 | K163269 | 000 |
| 00191375026082 | K163269 | 000 |
| 00191375026068 | K163269 | 000 |
| 00191375026044 | K163269 | 000 |
| 00191375026020 | K163269 | 000 |
| 00191375026013 | K163269 | 000 |
| 00191375025993 | K163269 | 000 |
| 00191375025979 | K163269 | 000 |
| 00191375025955 | K163269 | 000 |
| 00191375025931 | K163269 | 000 |
| 00191375025917 | K163269 | 000 |
| 00191375026211 | K163269 | 000 |