The following data is part of a premarket notification filed by Biomet Interpore Cross with the FDA for Regeneross Allograft Plus Minerlized.
| Device ID | K113645 |
| 510k Number | K113645 |
| Device Name: | REGENEROSS ALLOGRAFT PLUS MINERLIZED |
| Classification | Bone Grafting Material, Human Source |
| Applicant | BIOMET INTERPORE CROSS 181 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Contact | Kathleen Olivares |
| Correspondent | Kathleen Olivares BIOMET INTERPORE CROSS 181 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-12 |
| Decision Date | 2012-01-20 |
| Summary: | summary |