The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics.
| Device ID | K051614 |
| 510k Number | K051614 |
| Device Name: | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 -3015 |
| Contact | Rachel Kennedy |
| Correspondent | Rachel Kennedy LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 -3015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-17 |
| Decision Date | 2005-09-09 |
| Summary: | summary |