The following data is part of a premarket notification filed by Interventional Spine, Inc. with the FDA for Single Use Perpos Pls System, 4.5 Bone-lok Pls Implant.
| Device ID | K082795 |
| 510k Number | K082795 |
| Device Name: | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT |
| Classification | System, Facet Screw Spinal Device |
| Applicant | INTERVENTIONAL SPINE, INC. 13700 ALTON PKWY., SUITE 160 Irvine, CA 92618 |
| Contact | Carol Emerson |
| Correspondent | Carol Emerson INTERVENTIONAL SPINE, INC. 13700 ALTON PKWY., SUITE 160 Irvine, CA 92618 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2008-12-12 |
| Summary: | summary |