The following data is part of a premarket notification filed by Triage Medical Inc with the FDA for 4.5mm Bone-lok Facet Screw, Models Tfcd-45-3040s Or N; Sfcd-45-3040s Or N.
| Device ID | K043351 |
| 510k Number | K043351 |
| Device Name: | 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N |
| 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 | 2004-12-06 |
| Decision Date | 2005-02-18 |
| Summary: | summary |