The following data is part of a premarket notification filed by Neoss Ltd with the FDA for Neoss Implant System 03.25.
| Device ID | K090452 |
| 510k Number | K090452 |
| Device Name: | NEOSS IMPLANT SYSTEM 03.25 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NEOSS LTD 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James NEOSS LTD 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060440331466 | K090452 | 000 |
| 05060440335495 | K090452 | 000 |
| 05060440335501 | K090452 | 000 |
| 05060440333743 | K090452 | 000 |
| 05060440334108 | K090452 | 000 |
| 05060440334115 | K090452 | 000 |
| 05060440334122 | K090452 | 000 |
| 05060440331121 | K090452 | 000 |
| 05060440331138 | K090452 | 000 |
| 05060440331145 | K090452 | 000 |
| 05060440331268 | K090452 | 000 |
| 05060440331275 | K090452 | 000 |
| 05060440331282 | K090452 | 000 |
| 05060440335488 | K090452 | 000 |