The following data is part of a premarket notification filed by Life Spine with the FDA for Modification To Life Spine Cement Restrictor.
| Device ID | K061698 |
| 510k Number | K061698 |
| Device Name: | MODIFICATION TO 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 | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-16 |
| Decision Date | 2006-07-12 |
| Summary: | summary |