# Amendia, Inc.

- Location (FDA's records): Marietta, GA
- FDA decisions: 16 (2009–2016): 16 510(k) clearances
- Product codes: NKB (4), MAX (4), MRW (2), KWQ (2), MBI (1), OVE (1), MQP (1), OVD (1)
- 510(k) review time since 2016: median 177 days, against 124 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 47 (7 its own); citations of its devices by later devices: 38 (7 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
- Nuvasive, Inc.: 4 (https://510kreport.com/company/nuvasive)
- Depuyacromed: 2 (https://510kreport.com/company/depuyacromed)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Trans1 Incorporated: 2 (https://510kreport.com/company/trans1)
- Neurospine Innovations and Solutions: 2 (https://510kreport.com/company/neurospine-innovations-and-solutions)
- Spine360: 2 (https://510kreport.com/company/spine360)
- Zavation, LLC: 2 (https://510kreport.com/company/zavation)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)

## Firms that cite its devices most
- Spinal Elements, Inc.: 7 (https://510kreport.com/company/spinal-elements)
- 4Web, Inc.: 3 (https://510kreport.com/company/4web)
- MiRus, LLC: 3 (https://510kreport.com/company/mirus)
- Integrity Implants, Inc.: 2 (https://510kreport.com/company/integrity-implants)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Synchro Medical: 1 (https://510kreport.com/company/synchro-medical)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)

## Its most-cited devices
- K160924: Amendia Interbody Fusion Devices (2016), cited by 7
- K151322: Amendia Interbody Fusion Devices (2015), cited by 6
- K132925: Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link (2014), cited by 4
- K100265: Diamond Anterior Cervical Plate System (2010), cited by 4
- K092568: Spartan S3 Facet System (2009), cited by 4
- K133036: Apollo Suture Anchor System and Titan Screws (2014), cited by 3

## Recent decisions
- K160924: Amendia Interbody Fusion Devices (Nov 8, 2016)
- K161842: Overwatch Spine System (Oct 13, 2016)
- K152920: Savannah-T® Pedicle Screw System (Jul 8, 2016)
- K153152: Syzygy Stabilization System (Apr 27, 2016)
- K160291: Optimus ALIF System (Feb 18, 2016)
- K152972: Amendia Stand-Alone Cervical System (Jan 14, 2016)
- K151310: Amendia Interbody Fusion Devices (Jan 6, 2016)
- K152460: Rectangular Corpectomy Cage (Dec 22, 2015)

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