The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Kmi Cement Restrictor Implant.
| Device ID | K061465 |
| 510k Number | K061465 |
| Device Name: | KMI CEMENT RESTRICTOR IMPLANT |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Contact | John G Spampinato |
| Correspondent | John G Spampinato KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-26 |
| Decision Date | 2006-10-05 |
| Summary: | summary |