The following data is part of a premarket notification filed by Triage Medical, Inc. with the FDA for 3.8mm Cs Facet Compression Device.
| Device ID | K052043 |
| 510k Number | K052043 |
| Device Name: | 3.8MM CS FACET COMPRESSION DEVICE |
| 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 | 2005-07-28 |
| Decision Date | 2005-10-17 |
| Summary: | summary |