# Biomet Spine (Aka Ebi, LLC)

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 13 (2010–2014): 13 510(k) clearances
- Product codes: NKB (4), KWP (2), MAX (2), PDQ (1), OSH (1), FMF (1), NQW (1), KWQ (1)
- Predicates its devices cite: 88 (8 its own); citations of its devices by later devices: 47 (8 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ebi, L.P.: 14 (https://510kreport.com/company/ebi)
- Medtronic Sofamor Danek: 9 (https://510kreport.com/company/medtronic-sofamor-danek)
- Depuy Spine, Inc.: 7 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek USA, Inc.: 7 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Interpore Cross Intl.: 5 (https://510kreport.com/company/interpore-cross-intl)
- Synthes Spine: 4 (https://510kreport.com/company/synthes-spine)
- Biomet Spine: 4 (https://510kreport.com/company/biomet-spine)
- L&K BIOMED Co., Ltd.: 3 (https://510kreport.com/company/l-k-biomed)

## Firms that cite its devices most
- Precision Spine, Inc.: 4 (https://510kreport.com/company/precision-spine)
- Ebi, L.P.: 4 (https://510kreport.com/company/ebi)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Ulrich Medical USA: 2 (https://510kreport.com/company/ulrich-medical-usa)
- Aesculap Implant Systems, LLC: 2 (https://510kreport.com/company/aesculap-implant-systems)
- Nexus Spine, LLC: 1 (https://510kreport.com/company/nexus-spine)
- Medicrea International SA: 1 (https://510kreport.com/company/medicrea-international)

## Its most-cited devices
- K133518: Maxan Anterior Cervical Plate System (2014), cited by 12
- K113593: Nextgen Altius Oct System (2012), cited by 6
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), cited by 5
- K133746: Polaris Spinal System (2014), cited by 5
- K122378: Nextgen Altius Oct System (2012), cited by 4
- K131615: Polaris Spinal System (2013), cited by 4

## Recent decisions
- K133518: Maxan Anterior Cervical Plate System (Nov 5, 2014)
- K140710: Biomet Graft Delivery Syringes (Sep 4, 2014)
- K132373: Biomet Access System (Mar 27, 2014)
- K133746: Polaris Spinal System (Mar 12, 2014)
- K131615: Polaris Spinal System (Sep 4, 2013)
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (Feb 25, 2013)
- K123451: Polaris Spinal System - Ballista II Rods (Dec 3, 2012)
- K122989: Biomet Lateral Spacer System (Oct 24, 2012)

Source page: https://510kreport.com/company/biomet-spine-aka-ebi