The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Renova Internal Hex Implant System.
| Device ID | K032774 |
| 510k Number | K032774 |
| Device Name: | RENOVA INTERNAL HEX IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Diane Brinza |
| Correspondent | Diane Brinza LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2003-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D768R946048K0 | K032774 | 000 |
| D76843106K0 | K032774 | 000 |
| D76843105K0 | K032774 | 000 |
| D76843104K0 | K032774 | 000 |
| D76843103K0 | K032774 | 000 |
| D76843102K0 | K032774 | 000 |
| D76843100K0 | K032774 | 000 |
| D76843096K0 | K032774 | 000 |
| D76843094K0 | K032774 | 000 |
| D76843092K0 | K032774 | 000 |
| D76843090K0 | K032774 | 000 |
| D76843107K0 | K032774 | 000 |
| D76843108K0 | K032774 | 000 |
| D76843109K0 | K032774 | 000 |
| D768L280701K0 | K032774 | 000 |
| D76843121K0 | K032774 | 000 |
| D76843120K0 | K032774 | 000 |
| D76843119K0 | K032774 | 000 |
| D76843118K0 | K032774 | 000 |
| D76843116K0 | K032774 | 000 |
| D76843114K0 | K032774 | 000 |
| D76843113K0 | K032774 | 000 |
| D76843111K0 | K032774 | 000 |
| D76843110K0 | K032774 | 000 |
| D76843089K0 | K032774 | 000 |