# Biomet Spine

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 23 (2007–2016): 23 510(k) clearances
- Names in FDA's records: Biomet Spine (19); Biomet Spine, LLC (4)
- Product codes: NKB (5), MAX (5), OVD (4), OVE (2), KWQ (2), MQP (1), MQV (1), NKG (1), NVR (1), KWP (1)
- Predicates its devices cite: 75 (6 its own); citations of its devices by later devices: 64 (6 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ebi, L.P.: 18 (https://510kreport.com/company/ebi)
- Depuy Spine, Inc.: 9 (https://510kreport.com/company/depuy-spine)
- Interpore Cross Intl.: 8 (https://510kreport.com/company/interpore-cross-intl)
- Lanx, Inc.: 5 (https://510kreport.com/company/lanx)
- Stryker Spine: 5 (https://510kreport.com/company/stryker-spine)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Spinal Elements, Inc.: 3 (https://510kreport.com/company/spinal-elements)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)

## Firms that cite its devices most
- Ebi, L.P.: 6 (https://510kreport.com/company/ebi)
- Zimmer Biomet Spine, Inc.: 5 (https://510kreport.com/company/zimmer-biomet-spine)
- Biomet Spine (Aka Ebi, LLC): 4 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Spinal USA: 3 (https://510kreport.com/company/spinal-usa)
- Astura Medical: 3 (https://510kreport.com/company/astura-medical)
- Aesculap Implant Systems, LLC: 3 (https://510kreport.com/company/aesculap-implant-systems)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Precision Spine, Inc.: 2 (https://510kreport.com/company/precision-spine)

## Its most-cited devices
- K080646: C-Tek Maxan Anterior Cervical Plate System (2008), cited by 11
- K081395: Solitaire Peek-Optima Anterior Spinal System (2008), cited by 8
- K081952: Synergy Spinal System (6.35 Polaris) (2008), cited by 6
- K081501: Solitaire Anterior Spinal System (2008), cited by 5
- K141791: Biomet Fusion System (2014), cited by 4
- K091067: 5.5 Polaris Spinal System (2009), cited by 4

## Recent decisions
- K152622: Alta ACDF System (Jul 8, 2016)
- K153695: Biomet Spine Fusion System (Jan 21, 2016)
- K151974: Polaris Spinal System (Nov 13, 2015)
- K151064: Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System (Aug 12, 2015)
- K151483: Biomet Spine Fusion System (Jul 31, 2015)
- K151224: Lineum OCT Spine System (Jun 30, 2015)
- K142634: Biomet Spine Fusion System (Mar 12, 2015)
- K141791: Biomet Fusion System (Oct 9, 2014)

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