# Pinnacle Spine Group, LLC

- Location (FDA's records): Dallas, TX
- FDA decisions: 13 (2011–2017): 13 510(k) clearances
- Names in FDA's records: Pinnacle Spine Group, LLC (12); Pinnacle Spine Group (1)
- Product codes: MAX (8), FMF (3), ODP (1), NKB (1)
- Predicates its devices cite: 37 (14 its own); citations of its devices by later devices: 23 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- X-Spine Systems, Inc.: 3 (https://510kreport.com/company/x-spine-systems)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- Cutting Edge Spine, LLC: 1 (https://510kreport.com/company/cutting-edge-spine)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Micromedics, Inc.: 1 (https://510kreport.com/company/micromedics)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)

## Firms that cite its devices most
- Zimmer Knee Creations, Inc.: 2 (https://510kreport.com/company/zimmer-knee-creations)
- Biomet Spine (Aka Ebi, LLC): 2 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Centinel Spine, Inc.: 2 (https://510kreport.com/company/centinel-spine)
- Seohancare Co., Ltd.: 1 (https://510kreport.com/company/seohancare)
- Prism Surgical Designs Pty, Ltd.: 1 (https://510kreport.com/company/prism-surgical-designs)
- Spinal Surgical Strategies, LLC: 1 (https://510kreport.com/company/spinal-surgical-strategies)

## Its most-cited devices
- K121476: Infill Graft Delivery System (2012), cited by 4
- K103729: Infill Intervertebral Body Fusion Device (2011), cited by 4
- K111632: Infill Graft Delivery System (2011), cited by 3
- K121733: Infill Intervertebral Body Fusion Device (2012), cited by 3
- K133721: Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif Contour Oblique and the Infill 60 (2014), cited by 3
- K172349: InFill® Interbody Fusion Device (2017), cited by 1

## Recent decisions
- K172349: InFill® Interbody Fusion Device (Dec 14, 2017)
- K152259: InFill Interbody Fusion Device (Nov 19, 2015)
- K151184: InFill Interbody Fusion Devices (Jul 14, 2015)
- K150206: InFill Interbody Fusion Devices (Apr 3, 2015)
- K143488: InFill Graft Delivery System (Dec 17, 2014)
- K141282: PGS 5.5 MM Cannulated Pedicle Screw (Dec 2, 2014)
- K140066: Infill Cervical (May 5, 2014)
- K133721: Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif Contour Oblique and the Infill 60 (Mar 31, 2014)

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