# Spectrum Spine, LLC

- Location (FDA's records): Jasper, GA
- FDA decisions: 8 (2013–2026): 8 510(k) clearances
- Names in FDA's records: Spectrum Spine, LLC (4); Spectrum Spine, Inc. (3); Spectrum Spine (1)
- Product codes: MAX (4), ODP (2), MRW (1), NQW (1)
- 510(k) review time since 2016: median 223 days, against 97 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 30 (9 its own); citations of its devices by later devices: 13 (9 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
- Coalign Innovations, Inc.: 3 (https://510kreport.com/company/coalign-innovations)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Eminent Spine: 2 (https://510kreport.com/company/eminent-spine)
- Anjon Holdings, LLC: 2 (https://510kreport.com/company/anjon-holdings)
- Ldr Spine USA: 1 (https://510kreport.com/company/ldr-spine-usa)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Kiscomedica S.A.: 1 (https://510kreport.com/company/kiscomedica)

## Firms that cite its devices most
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- SurGenTec, LLC: 1 (https://510kreport.com/company/surgentec)
- Choicespine, LP: 1 (https://510kreport.com/company/choicespine)
- NanoHive Medical, LLC: 1 (https://510kreport.com/company/nanohive-medical)

## Its most-cited devices
- K240838: Spectrum Spine Cervical Cage System (2024), cited by 4
- K201024: Expandable Titanium PLIF/TLIF System (2021), cited by 3
- K173518: Spectrum Spine Expandable Cages (SSEC) (2019), cited by 2
- K243074: Spectrum Spine Lumbar Cage System (2025), cited by 2
- K132126: Spectrum Spine Fenestrated Facet Screw System (2013), cited by 1
- K122822: Spectrum Spine Laminoplasty Plating System (2013), cited by 1

## Recent decisions
- K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (Mar 30, 2026)
- K253377: Expandable Titanium PLIF/TLIF System (Oct 24, 2025)
- K243074: Spectrum Spine Lumbar Cage System (Apr 4, 2025)
- K240838: Spectrum Spine Cervical Cage System (May 30, 2024)
- K201024: Expandable Titanium PLIF/TLIF System (Apr 29, 2021)
- K173518: Spectrum Spine Expandable Cages (SSEC) (Mar 7, 2019)
- K132126: Spectrum Spine Fenestrated Facet Screw System (Oct 28, 2013)
- K122822: Spectrum Spine Laminoplasty Plating System (Feb 7, 2013)

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