The following data is part of a premarket notification filed by Biomet 3i Llc with the FDA for Tsx Implants.
| Device ID | K220978 |
| 510k Number | K220978 |
| Device Name: | TSX Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
| Contact | Mariela Cabarcas |
| Correspondent | Mariela Cabarcas Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868045328 | K220978 | 000 |
| 00844868045120 | K220978 | 000 |
| 00844868045113 | K220978 | 000 |
| 00844868045106 | K220978 | 000 |
| 00844868045090 | K220978 | 000 |
| 00844868045083 | K220978 | 000 |
| 00844868045076 | K220978 | 000 |
| 00844868045069 | K220978 | 000 |
| 00844868045052 | K220978 | 000 |
| 00844868045045 | K220978 | 000 |
| 00844868045038 | K220978 | 000 |
| 00844868045021 | K220978 | 000 |
| 00844868045014 | K220978 | 000 |
| 00844868045007 | K220978 | 000 |
| 00844868045144 | K220978 | 000 |
| 00844868045151 | K220978 | 000 |
| 00844868045304 | K220978 | 000 |
| 00844868045298 | K220978 | 000 |
| 00844868045281 | K220978 | 000 |
| 00844868045274 | K220978 | 000 |
| 00844868045267 | K220978 | 000 |
| 00844868045243 | K220978 | 000 |
| 00844868045236 | K220978 | 000 |
| 00844868045229 | K220978 | 000 |
| 00844868045212 | K220978 | 000 |
| 00844868045205 | K220978 | 000 |
| 00844868045182 | K220978 | 000 |
| 00844868045175 | K220978 | 000 |
| 00844868045168 | K220978 | 000 |
| 00844868044994 | K220978 | 000 |