The following data is part of a premarket notification filed by Tedan Surgical Innovations Llc with the FDA for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems.
| Device ID | K161318 |
| 510k Number | K161318 |
| Device Name: | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | TEDAN SURGICAL INNOVATIONS LLC 12615 W. AIRPORT BLVD, SUITE 200 Sugar Land, TX 77478 |
| Contact | John Willis |
| Correspondent | John Willis TEDAN SURGICAL INNOVATIONS LLC 12615 W. AIRPORT BLVD, SUITE 200 Sugar Land, TX 77478 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2017-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851797006818 | K161318 | 000 |
| 00851797006641 | K161318 | 000 |
| 00851797006634 | K161318 | 000 |
| 00851797006627 | K161318 | 000 |
| 00851797006610 | K161318 | 000 |
| 00851797006603 | K161318 | 000 |
| 00851797006597 | K161318 | 000 |
| 00851797006580 | K161318 | 000 |
| 00851797006573 | K161318 | 000 |
| 00851797006566 | K161318 | 000 |
| 00851797006559 | K161318 | 000 |
| 00851797006542 | K161318 | 000 |
| 00851797006535 | K161318 | 000 |
| 00851797006528 | K161318 | 000 |
| 00851797006658 | K161318 | 000 |
| 00851797006665 | K161318 | 000 |
| 00851797006672 | K161318 | 000 |
| 00851797006801 | K161318 | 000 |
| 00851797006795 | K161318 | 000 |
| 00851797006788 | K161318 | 000 |
| 00851797006771 | K161318 | 000 |
| 00851797006764 | K161318 | 000 |
| 00851797006757 | K161318 | 000 |
| 00851797006740 | K161318 | 000 |
| 00851797006733 | K161318 | 000 |
| 00851797006726 | K161318 | 000 |
| 00851797006719 | K161318 | 000 |
| 00851797006702 | K161318 | 000 |
| 00851797006696 | K161318 | 000 |
| 00851797006689 | K161318 | 000 |
| 00851797006511 | K161318 | 000 |