Triage Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Triage Medical, Inc.” (first 2001, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 6 | 6 |
| MRW | System, Facet Screw Spinal Device | 4 | 4 |
| HTN | Washer, Bolt Nut | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Triage Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062391 | DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 | MRW | 2006-09-14 | 29 |
| K052043 | 3.8MM CS FACET COMPRESSION DEVICE | MRW | 2005-10-17 | 81 |
| K051949 | 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 | MRW | 2005-08-05 | 21 |
| K043351 | 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N | MRW | 2005-02-18 | 74 |
| K042244 | BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE | HWC | 2004-09-16 | 28 |
| K040250 | BONE-LOK HP WASHER | HTN | 2004-03-23 | 50 |
| K014304 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S | HWC | 2002-03-27 | 86 |
| K014243 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 | HWC | 2002-03-26 | 90 |
| K012818 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX | HWC | 2001-11-20 | 90 |
| K012817 | HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED | HWC | 2001-11-20 | 90 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Triage Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Triage Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Triage Medical, Inc.” (first 2001, latest 2006), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Triage Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Triage Medical, Inc. is 74 days.
Which FDA product codes appear under Triage Medical, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 6); MRW (System, Facet Screw Spinal Device, 4); HTN (Washer, Bolt Nut, 1).
Next steps
- See all 11 Triage Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Triage Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.