The following data is part of a premarket notification filed by Triage Medical, Inc. with the FDA for Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 And 9045-02; Compression Tool, Model 6113-00.
| Device ID | K062391 |
| 510k Number | K062391 |
| Device Name: | DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 |
| Classification | System, Facet Screw Spinal Device |
| Applicant | TRIAGE MEDICAL, INC. 13700 ALTON PKWY., SUITE 160 Irvine, CA 92618 |
| Contact | Gayle Hirota |
| Correspondent | Gayle Hirota TRIAGE MEDICAL, 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 | 2006-08-16 |
| Decision Date | 2006-09-14 |
| Summary: | summary |