Ebi, L.P.
United StatesFDA 510(k) applicant, unverified
- Devices
- 96
- FDA recalls
- 47
At a glance
Market reach
- United States
- FDA recalls
What Ebi, L.P. makes
Ebi, L.P. manufactures spinal fixation systems, including anterior cervical plates, expandable implants, and steerable catheter systems for fluoroscopic guidance. Their portfolio includes modular spinal fixation devices like the Spinelink and P148 systems, as well as pelvic fixators and line extensions to existing spinal arrays. The company also produces modifications to established systems, such as updates to the XFix DFS and TargetCath catheter systems.
The company’s devices are regulated under FDA pathways, with Class II and Class III classifications. Products are authorised via 510(k) clearances and Premarket Approvals (PMA). The manufacturer is based in the United States.
Catalogue
Search and filter all 96 devicesShowing 1-50 of 96
FDA recalls
FDA recall records list 47 recalls initiated by Ebi, L.P., the earliest on 2003-06-17 and the most recent on 2009-04-02. By recorded status: 47 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 2 Apr 2009 Z-2277-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2278-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2279-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2280-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2281-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2282-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2283-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2284-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2285-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2286-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2277-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Show the 25 most recent of 47 recalls
2009
- 2 Apr 2009 Z-2287-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2288-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2289-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2290-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2291-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2292-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2293-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2294-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2295-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2296-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2297-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2298-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2299-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2300-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2301-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
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- 2 Apr 2009 Z-2287-2009 Unclassified (pre-2012) Terminated Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Frequently asked questions
How many devices does Ebi, L.P. have in the registry?
The registry currently lists 96 devices for Ebi, L.P.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ebi, L.P.'s devices?
Among its 50 most recently registered devices, Ebi, L.P. has devices listed in FDA 510(k) (50 devices).
What risk classes do Ebi, L.P.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ebi, L.P.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ebi, L.P.?
FDA recall records list 47 recalls initiated by Ebi, L.P., the most recent initiated on 2009-04-02. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ebi, L.P. in the registry?
The most recently registered devices listed for Ebi, L.P. include MODIFICATION TO EBI XFIX DFS SYSTEM, MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM, EBI SPINELINK - II SPINAL FIXATION SYSTEM and MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM.