The following data is part of a premarket notification filed by Interventional Spine, Inc. with the FDA for Perpos Fcd-2 System (single Patient Use), Anchor, Stabilizer.
| Device ID | K090767 |
| 510k Number | K090767 |
| Device Name: | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER |
| 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 | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-23 |
| Decision Date | 2009-06-11 |
| Summary: | summary |