# Spinecraft, LLC

- Location (FDA's records): Westmont, IL
- FDA decisions: 18 (2006–2026): 18 510(k) clearances
- Names in FDA's records: Spinecraft, LLC (12); SpineCraft (3); Spinecraft, Inc. (3)
- Product codes: NKB (6), ODP (3), KWQ (3), KWP (2), MNH (1), NKG (1), OLO (1), MQV (1)
- 510(k) review time since 2016: median 59 days, against 88 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 127 (26 its own); citations of its devices by later devices: 44 (26 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 19 (https://510kreport.com/company/depuy-spine)
- Stryker Spine: 9 (https://510kreport.com/company/stryker-spine)
- Globus Medical, Inc.: 7 (https://510kreport.com/company/globus-medical)
- Depuyacromed: 7 (https://510kreport.com/company/depuyacromed)
- Medtronic Sofamor Danek USA, Inc.: 6 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Synthes Spine: 4 (https://510kreport.com/company/synthes-spine)
- Synthes (USA) Products, LLC: 3 (https://510kreport.com/company/synthes-usa-products)
- Eminent Spine: 3 (https://510kreport.com/company/eminent-spine)

## Firms that cite its devices most
- Accel Spine: 3 (https://510kreport.com/company/accel-spine)
- L&K BIOMED Co., Ltd.: 3 (https://510kreport.com/company/l-k-biomed)
- Corelink, LLC: 2 (https://510kreport.com/company/corelink)
- SI-BONE, Inc.: 1 (https://510kreport.com/company/si-bone)
- GS Medical Co., Ltd.: 1 (https://510kreport.com/company/gs-medical)
- Corentec Co., Ltd.: 1 (https://510kreport.com/company/corentec)
- Nexxt Spine, LLC: 1 (https://510kreport.com/company/nexxt-spine)
- Ulrich Medical USA: 1 (https://510kreport.com/company/ulrich-medical-usa)

## Its most-cited devices
- K062513: Apex Spine System (2006), cited by 8
- K102488: Apex Spine System W/ Cocr Rods (2010), cited by 7
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer (2010), cited by 7
- K090887: Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion Cages (2009), cited by 5
- K150417: Astra Spine System (2015), cited by 4
- K110906: Apex Spine System (2011), cited by 3

## Recent decisions
- K253260: ORIO-3D Cage System (Apr 16, 2026)
- K260015: ANTERIS Thoracolumbar Plate System (Mar 4, 2026)
- K223301: ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System (Jul 20, 2023)
- K223273: ASTRA Spine System (Dec 22, 2022)
- K211935: ORIO-Ti Intervertebral Body Fusion Cage System (Sep 30, 2021)
- K211323: ASTRA Spine System (Jun 3, 2021)
- K181350: ASTRA-OCT Spine System (Jul 6, 2018)
- K143683: APEX-DL Spine System (May 22, 2015)

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