Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Triage Medical, Inc. · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

74 daysmedian FDA review time

90 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K062391	DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MOD	Triage Medical, Inc.	2006-09-14	29	1
K052043	3.8MM CS FACET COMPRESSION DEVICE	Triage Medical, Inc.	2005-10-17	81	0
K051949	4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODE	Triage Medical, Inc.	2005-08-05	21	0
K043351	4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-	Triage Medical, Inc.	2005-02-18	74	1
K042244	BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE	Triage Medical, Inc.	2004-09-16	28	0
K040250	BONE-LOK HP WASHER	Triage Medical, Inc.	2004-03-23	50	0
K014304	BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-305	Triage Medical, Inc.	2002-03-27	86	0
K014243	BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXT	Triage Medical, Inc.	2002-03-26	90	0
K012818	HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX	Triage Medical, Inc.	2001-11-20	90	0
K012817	HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED	Triage Medical, Inc.	2001-11-20	90	0
K012280	TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2	Triage Medical, Inc.	2001-08-17	29	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda