# Ebi, L.P.

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 104 (1983–2020): 103 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Ebi, L.P. (96); Ebi, LLC (4); Ebi, Inc. (4)
- Product codes: KTT (36), NKB (11), KWQ (10), MNH (6), HRS (6), MQP (6), MNI (4), DZE (4), MAX (3), HAW (2), KWP (2), HRX (2)
- Predicates its devices cite: 187 (63 its own); citations of its devices by later devices: 225 (63 its own)
- Recalls linked to its devices: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Electro-Biology, Inc.: 26 (https://510kreport.com/company/electro-biology)
- Synthes (Usa): 14 (https://510kreport.com/company/synthes-usa)
- Interpore Cross Intl.: 11 (https://510kreport.com/company/interpore-cross-intl)
- Ebi Electro Biology: 7 (https://510kreport.com/company/ebi-electro-biology)
- Biomet Spine: 6 (https://510kreport.com/company/biomet-spine)
- Z-Kat, Inc.: 4 (https://510kreport.com/company/z-kat)
- Biomet Spine (Aka Ebi, LLC): 4 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Biomet, Inc.: 4 (https://510kreport.com/company/biomet)

## Firms that cite its devices most
- Biomet Trauma: 31 (https://510kreport.com/company/biomet-trauma)
- Biomet Spine: 18 (https://510kreport.com/company/biomet-spine)
- Biomet Spine (Aka Ebi, LLC): 14 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Tecnologia Y Diseno Industrial, S.A DE C.V: 8 (https://510kreport.com/company/tecnologia-y-diseno-industrial-s-a-de-c-v)
- Corelink, LLC: 6 (https://510kreport.com/company/corelink)
- Biomet Trauma (Aka Ebi, Lp): 5 (https://510kreport.com/company/biomet-trauma-aka-ebi)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)

## Its most-cited devices
- K061441: Ebi 5.5 Helical Flange Spinal System (2006), cited by 9
- K090203: 5.5 Helical Flange Spinal System, Polaris Components (2009), cited by 8
- K042268: Ebi Cas Spine Spacer System (2004), cited by 8
- K092336: C-Thru Spinal System (2009), cited by 7
- K082406: Expandable Peek-Optima Implant (2009), cited by 7
- K993886: Ebi Xfix Vision Fixation System (1999), cited by 7

## Recent decisions
- K190837: Internal Hex Implant System (Jan 22, 2020)
- K170031: Internal Octa Implant System (Aug 31, 2017)
- K142426: EBI External Implant System (Mar 27, 2015)
- K140734: Nextgen Altius Oct System (Dec 15, 2014)
- K140123: Polaris Spinal System -Translation Screw (Apr 24, 2014)
- K113796: Solitaire-C Cervical Spacer System (Apr 26, 2012)
- K111376: Construx External Fixation Device (Aug 3, 2011)
- K100438: Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System (Jun 23, 2010)

Source page: https://510kreport.com/company/ebi