# Meditech Spine, LLC

- Location (FDA's records): Atlanta, GA
- FDA decisions: 10 (2015–2021): 10 510(k) clearances
- Product codes: KWQ (6), ODP (3), MAX (1)
- 510(k) review time since 2016: median 89 days, against 92 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 18 (7 its own); citations of its devices by later devices: 21 (7 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
- Meditech Advisors, LLC: 4 (https://510kreport.com/company/meditech-advisors)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Centinel Spine, Inc.: 1 (https://510kreport.com/company/centinel-spine)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Innovative Spinal Technologies, Inc.: 1 (https://510kreport.com/company/innovative-spinal-technologies)

## Firms that cite its devices most
- Curiteva, Inc.: 3 (https://510kreport.com/company/curiteva)
- Amendia, Inc.: 1 (https://510kreport.com/company/amendia)
- Ht Medical, LLC: 1 (https://510kreport.com/company/ht-medical)
- Keos: 1 (https://510kreport.com/company/keos)
- Bethesda Medical Devices: 1 (https://510kreport.com/company/bethesda-medical-devices)
- NGMedical GmbH: 1 (https://510kreport.com/company/ngmedical)
- Choicespine, LP: 1 (https://510kreport.com/company/choicespine)
- Cutting Edge Spine, LLC: 1 (https://510kreport.com/company/cutting-edge-spine)

## Its most-cited devices
- K171538: Cure™ Lumbar Plate System (2017), cited by 6
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices (2015), cited by 4
- K142345: Talos-C (HA) Cervical Intervertebral Body Fusion Devices (2015), cited by 4
- K170395: Talos® Lumbar (HA) PEEK IBF Devices (2017), cited by 3
- K160604: Cure™ Anterior Cervical Plate (ACP) System (2016), cited by 2
- K181543: Cure™ OPEL-C Plate System (2018), cited by 1

## Recent decisions
- K210286: Cure 2.0 Anterior Cervical Plate (ACP) System (Mar 18, 2021)
- K201506: Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System (Sep 11, 2020)
- K201136: Cure™ Lumbar Plate System (May 12, 2020)
- K181543: Cure™ OPEL-C Plate System (Aug 31, 2018)
- K180090: Cure™ Lumbar Plate System (Apr 23, 2018)
- K171538: Cure™ Lumbar Plate System (Jun 16, 2017)
- K170395: Talos® Lumbar (HA) PEEK IBF Devices (Jun 2, 2017)
- K160604: Cure™ Anterior Cervical Plate (ACP) System (Jul 1, 2016)

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