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

Amendia, Inc. — Predicate Candidate Screening

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

116 daysmedian FDA review time

233 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K160924	Amendia Interbody Fusion Devices	Amendia, Inc.	2016-11-08	218	0
K161842	Overwatch Spine System	Amendia, Inc.	2016-10-13	100	0
K152920	Savannah-T® Pedicle Screw System	Amendia, Inc.	2016-07-08	280	0
K153152	Syzygy Stabilization System	Amendia, Inc.	2016-04-27	177	0
K160291	Optimus ALIF System	Amendia, Inc.	2016-02-18	15	0
K152972	Amendia Stand-Alone Cervical System	Amendia, Inc.	2016-01-14	98	1
K151310	Amendia Interbody Fusion Devices	Amendia, Inc.	2016-01-06	233	0
K152460	Rectangular Corpectomy Cage	Amendia, Inc.	2015-12-22	116	0
K152455	Amendia Cervical Plate System	Amendia, Inc.	2015-10-15	48	0
K151322	Amendia Interbody Fusion Devices	Amendia, Inc.	2015-09-10	115	1
K150395	Omega LIF System	Amendia, Inc.	2015-08-10	173	0
K133036	APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS	Amendia, Inc.	2014-03-06	161	0
K132925	SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MON	Amendia, Inc.	2014-02-11	146	0
K113011	SPARTAN S3 FACET SYSTEM	Amendia, Inc.	2011-12-06	56	0
K100265	DIAMOND ANTERIOR CERVICAL PLATE SYSTEM	Amendia, Inc.	2010-05-13	104	0
K092568	SPARTAN S3 FACET SYSTEM	Amendia, Inc.	2009-11-17	89	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