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

Xtremi-T, LLC — Predicate Candidate Screening

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

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050388	REFIX INTERNAL FRACTURE FIXATION SCREWS	Xtremi-T, LLC	2005-09-07	204	0
K043339	REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA),	Xtremi-T, LLC	2005-04-18	136	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