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

Ebi, L.P. — Predicate Candidate Screening

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

30 daysmedian FDA review time

113 days90th percentile

95clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K100438	POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FI	Ebi, L.P.	2010-06-23	126	0
K100220	POLARIS SPINAL SYSTEM	Ebi, L.P.	2010-05-17	111	0
K093880	PEANUT GROWTH CONTROL PLATING SYSTEM	Ebi, L.P.	2010-04-16	119	1
K092574	ESL SPINAL SYSTEM	Ebi, L.P.	2010-02-04	167	0
K093057	BIOMET VISION FOOTRING SYSTEM	Ebi, L.P.	2009-12-01	62	0
K092336	C-THRU SPINAL SYSTEM	Ebi, L.P.	2009-10-15	72	0
K091381	IBEX SPINAL SYSTEM	Ebi, L.P.	2009-08-07	88	0
K090203	5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS	Ebi, L.P.	2009-07-30	184	0
K090523	POLARIS SPINAL SYSTEM	Ebi, L.P.	2009-07-01	125	0
K082406	EXPANDABLE PEEK-OPTIMA IMPLANT	Ebi, L.P.	2009-01-14	146	0
K082187	BIOMET ANTERIOR LUMBAR PLATE	Ebi, L.P.	2008-11-13	101	0
K063346	PRO OSTEON 500R	Ebi, L.P.	2007-04-18	166	0
K062494	EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM	Ebi, L.P.	2006-10-19	55	1
K062810	SOLITAIRE ANTERIOR SPINAL SYSTEM	Ebi, L.P.	2006-10-17	28	0
K062685	EBI ARAY SPINAL SYSTEM	Ebi, L.P.	2006-10-06	28	1
K061978	EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM	Ebi, L.P.	2006-08-11	29	0
K061441	EBI 5.5 HELICAL FLANGE SPINAL SYSTEM	Ebi, L.P.	2006-07-25	62	2
K061563	EBI ARRAY SPINAL SYSTEM	Ebi, L.P.	2006-06-23	18	0
K061016	EBI ESL PEEK-OPTIMA SPINE SYSTEM	Ebi, L.P.	2006-06-08	56	0
K061098	EBI OPTILOCK PERIARTICULAR PLATING SYSTEM	Ebi, L.P.	2006-05-24	35	0
K060148	EBI VERTEBROPLASTY SYSTEMS	Ebi, L.P.	2006-03-13	53	0
K060379	EBI ANTERIOR CERVICAL PLATE SYSTEM	Ebi, L.P.	2006-03-06	20	0
K052239	EBI DYNAFIX VISION FOOTPLATE SYSTEM	Ebi, L.P.	2005-09-21	35	0
K051724	ACUMEN IMAGE GUIDED SURGICAL SYSTEM	Ebi, L.P.	2005-07-19	22	0
K050118	EBI TROCHANTERIC NAIL SYSTEM	Ebi, L.P.	2005-02-16	29	3
K042772	EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIX	Ebi, L.P.	2004-12-13	69	0
K042268	EBI CAS SPINE SPACER SYSTEM	Ebi, L.P.	2004-10-27	65	0
K042237	EBI PERIARTICULAR PLATING SYSTEM	Ebi, L.P.	2004-09-16	29	10
K033918	EBI LACTOSORB GRAFT CONTAINMENT SYSTEM	Ebi, L.P.	2004-08-16	242	0
K040935	EBI XFIX DFS SYSTEM	Ebi, L.P.	2004-07-06	88	0
K040908	EBI DISTAL RADIUS PLATING SYSTEM	Ebi, L.P.	2004-06-25	79	0
K040833	MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM	Ebi, L.P.	2004-04-29	29	0
K040482	EBI ESL SPINE SPACER SYSTEM	Ebi, L.P.	2004-04-16	51	0
K033312	EBI TOP LOADING MAS SPINAL FIXATION SYSTEM	Ebi, L.P.	2004-01-13	91	0
K033635	MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM	Ebi, L.P.	2003-12-03	14	0
K031732	EBI ACUMEN SURGICAL NAVIGATION SYSTEM	Ebi, L.P.	2003-10-15	133	0
K031919	EBI XFIX DFS SYSTEM	Ebi, L.P.	2003-09-04	73	0
K032390	MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHE	Ebi, L.P.	2003-08-29	25	0
K031354	EBI OMEGA21 SPINAL FIXATION SYSTEM	Ebi, L.P.	2003-08-06	99	0
K031424	EBI SPINELINK SPINAL FIXATION SYSTEM	Ebi, L.P.	2003-07-22	77	0
K031355	EBI SPINELINK - II SPINAL FIXATION SYSTEM	Ebi, L.P.	2003-07-22	84	0
K031093	EBI XFIX OPTIROM KNEE FIXATOR	Ebi, L.P.	2003-07-10	94	0
K031423	EBI P148 SPINAL FIXATION SYSTEM	Ebi, L.P.	2003-06-27	52	0
K031645	EBI XFIX DFS SYSTEM	Ebi, L.P.	2003-06-25	28	0
K030706	EBI DYNAFIX COMPRESSION BONE SCREW	Ebi, L.P.	2003-03-20	14	0
K030372	MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM	Ebi, L.P.	2003-03-06	30	0
K024248	MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION S	Ebi, L.P.	2003-01-22	30	0
K024129	MODIFICATION TO EBI XFIX DFS SYSTEM	Ebi, L.P.	2003-01-15	30	0
K023233	EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM	Ebi, L.P.	2002-12-13	77	1
K023399	EBI XFIX DFS SYSTEM	Ebi, L.P.	2002-10-25	16	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