The following data is part of a premarket notification filed by Life Spine with the FDA for Life Spine Cement Restrictor.
| Device ID | K060247 |
| 510k Number | K060247 |
| Device Name: | LIFE SPINE CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60195 |
| Contact | Erin Malloy |
| Correspondent | Erin Malloy LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60195 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-31 |
| Decision Date | 2006-05-11 |
| Summary: | summary |