The following data is part of a premarket notification filed by Neoss Ltd with the FDA for Neoss Proactive Tapered Implant.
| Device ID | K113376 |
| 510k Number | K113376 |
| Device Name: | NEOSS PROACTIVE TAPERED IMPLANT |
| 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 | 2011-11-16 |
| Decision Date | 2012-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060440333040 | K113376 | 000 |
| 05060440333972 | K113376 | 000 |
| 05060440333965 | K113376 | 000 |
| 05060440333934 | K113376 | 000 |
| 05060440333927 | K113376 | 000 |
| 05060440333897 | K113376 | 000 |
| 05060440335181 | K113376 | 000 |
| 05060440334436 | K113376 | 000 |
| 05060440334429 | K113376 | 000 |
| 05060440334412 | K113376 | 000 |
| 05060440333989 | K113376 | 000 |
| 05060440333996 | K113376 | 000 |
| 05060440334009 | K113376 | 000 |
| 05060440333033 | K113376 | 000 |
| 05060440334276 | K113376 | 000 |
| 05060440334269 | K113376 | 000 |
| 05060440334252 | K113376 | 000 |
| 05060440334245 | K113376 | 000 |
| 05060440334238 | K113376 | 000 |
| 05060440334221 | K113376 | 000 |
| 05060440334047 | K113376 | 000 |
| 05060440334016 | K113376 | 000 |
| 05060440334405 | K113376 | 000 |