The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for Explant Osteonecrosis Intervention Implant Removal System.
| Device ID | K050766 |
| 510k Number | K050766 |
| Device Name: | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-25 |
| Decision Date | 2005-05-26 |
| Summary: | summary |