The following data is part of a premarket notification filed by Spinesmith Holdings, Llc with the FDA for Celling Aspiration Needle.
| Device ID | K180807 |
| 510k Number | K180807 |
| Device Name: | Celling Aspiration Needle |
| Classification | Instrument, Biopsy |
| Applicant | SpineSmith Holdings, LLC 4719 S Congress Ave Austin, TX 78745 |
| Contact | Clifton (chris) Naivar |
| Correspondent | Clifton (chris) Naivar SpineSmith Holdings, LLC 4719 S Congress Ave Austin, TX 78745 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-28 |
| Decision Date | 2018-05-24 |
| Summary: | summary |