Medical device manufacturer

Ebi, L.P.

Ebi, L.P. holds 95 FDA 510(k) clearances across 18 product codes. Median elapsed review time is 30 days. openFDA lists 47 recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 95
Product codes: 18
Median review: 30 days
Recall records: 47

How does FDA spell Ebi, L.P.?

FDA publishes this company under 2 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published it	Dataset	Matched by
EBI, L.P.	device/recall	normalised
Ebi, L.P.	device/510k	normalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Ebi, L.P. file in?

18 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	35	28 days	1 December 2009
KWQ	Appliance, Fixation, Spinal Intervertebral Body	10	28 days	13 November 2008
NKB	Thoracolumbosacral Pedicle Screw System	10	84 days	23 June 2010
HRS	Plate, Fixation, Bone	6	55 days	16 April 2010
MNH	Orthosis, Spondylolisthesis Spinal Fixation	6	30 days	25 July 2006
MQP	Spinal Vertebral Body Replacement Device	6	56 days	15 October 2009
MNI	Orthosis, Spinal Pedicle Fixation	4	29 days	11 August 2006
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	3	146 days	4 February 2010
BSO	Catheter, Conduction, Anesthetic	2	25 days	29 August 2003
HAW	Neurological Stereotaxic Instrument	2	22 days	19 July 2005
HRX	Arthroscope	2	17 days	9 February 2001
MQV	Filler, Bone Void, Calcium Compound	2	88 days	18 April 2007
NDF	Plate, Fixation, Bone, Non-Spinal, Metallic	2	76 days	12 August 2002
HSB	Rod, Fixation, Intramedullary And Accessories	1	29 days	16 February 2005
HWC	Screw, Fixation, Bone	1	14 days	20 March 2003
KWP	Appliance, Fixation, Spinal Interlaminal	1	113 days	27 November 2001
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	1	30 days	13 December 2001
NDN	Cement, Bone, Vertebroplasty	1	53 days	13 March 2006

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Ebi, L.P. had a recall?

openFDA lists 47 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

Z-2277-2009TerminatedHSB2 April 2009
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Z-2278-2009TerminatedHSB2 April 2009
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Z-2279-2009TerminatedHSB2 April 2009
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Z-2280-2009TerminatedHSB2 April 2009
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Z-2281-2009TerminatedHSB2 April 2009
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

Showing the 5 most recently initiated of 47.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Ebi, L.P. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K100438	POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM	NKB	23 June 2010	126
K100220	POLARIS SPINAL SYSTEM	NKB	17 May 2010	111
K093880	PEANUT GROWTH CONTROL PLATING SYSTEM	HRS	16 April 2010	119
K092574	ESL SPINAL SYSTEM	MAX	4 February 2010	167
K093057	BIOMET VISION FOOTRING SYSTEM	KTT	1 December 2009	62
K092336	C-THRU SPINAL SYSTEM	MQP	15 October 2009	72
K091381	IBEX SPINAL SYSTEM	MAX	7 August 2009	88
K090203	5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS	NKB	30 July 2009	184
K090523	POLARIS SPINAL SYSTEM	NKB	1 July 2009	125
K082406	EXPANDABLE PEEK-OPTIMA IMPLANT	MAX	14 January 2009	146

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.