The following data is part of a premarket notification filed by Kensey Nash Cororation with the FDA for Kensey Nash Bone Void Filler Xc.
| Device ID | K120141 |
| 510k Number | K120141 |
| Device Name: | KENSEY NASH BONE VOID FILLER XC |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | KENSEY NASH CORORATION 735 PENNSYLVANIA DRIVE Exton, PA 19464 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi KENSEY NASH CORORATION 735 PENNSYLVANIA DRIVE Exton, PA 19464 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-05-04 |
| Summary: | summary |