The following data is part of a premarket notification filed by Life Spine with the FDA for Pilot Posterior Lumbar Plating System.
| Device ID | K061364 |
| 510k Number | K061364 |
| Device Name: | PILOT POSTERIOR LUMBAR PLATING SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-16 |
| Decision Date | 2006-09-05 |
| Summary: | summary |