# Globus Medical, Inc.

- Location (FDA's records): Audubon, PA
- FDA decisions: 176 (2003–2026): 175 510(k) clearances and 1 original PMA approval
- Product codes: NKB (24), MAX (20), KWQ (15), OLO (13), MQP (11), OVD (11), HRS (9), MQV (7), ODP (7), KWP (7), OVE (4), LPH (4)
- 510(k) review time since 2016: median 111 days, against 95 for FDA's reviews in the same codes and years (35 of 88 faster)
- Predicates its devices cite: 790 (468 its own); citations of its devices by later devices: 852 (468 its own)
- Recalls linked to its devices: 29 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 39 (https://510kreport.com/company/synthes-usa)
- Nu Vasive, Incorporated: 25 (https://510kreport.com/company/nu-vasive)
- Medtronic Sofamor Danek: 17 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 16 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Stelkast Company: 16 (https://510kreport.com/company/stelkast)
- Synthes Spine: 12 (https://510kreport.com/company/synthes-spine)
- Smith & Nephew, Inc.: 12 (https://510kreport.com/company/smith-nephew)
- Nuvasive, Inc.: 9 (https://510kreport.com/company/nuvasive)

## Firms that cite its devices most
- Life Spine, Inc.: 24 (https://510kreport.com/company/life-spine)
- Astura Medical: 12 (https://510kreport.com/company/astura-medical)
- K2m, Inc.: 12 (https://510kreport.com/company/k2m)
- Huvexel Co., Ltd.: 11 (https://510kreport.com/company/huvexel)
- Alphatec Spine, Inc.: 11 (https://510kreport.com/company/alphatec-spine)
- Spine Wave, Inc.: 10 (https://510kreport.com/company/spine-wave)
- Camber Spine Technologies: 10 (https://510kreport.com/company/camber-spine-technologies)
- Nu Vasive, Incorporated: 8 (https://510kreport.com/company/nu-vasive)

## Its most-cited devices
- K102293: Caliber Spacer (2011), cited by 31
- K061202: Revere Stabilization System (2006), cited by 30
- K072970: Patriot Spacers (2008), cited by 29
- K171651: Excelsius GPS (2017), cited by 28
- K113447: Rise Spacer (2012), cited by 27
- K123231: Caliber Spacers (2013), cited by 24

## Recent decisions
- K262779: ANTHEM™ Fracture System (Oct 23, 2026)
- K254043: TRIVANCE™ Hip Stem (Aug 4, 2026)
- K262251: ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (Jul 31, 2026)
- K253739: SCRIPT™ Rods, CREO™ Stabilization System,  REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (May 7, 2026)
- K253401: SCRIPT™ Implant System (Apr 29, 2026)
- K261043: AUTOBAHN™ Nailing System (Apr 24, 2026)
- K252166: RIB LINK™ Fixation System (Feb 26, 2026)
- K253876: HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (Dec 22, 2025)

Source page: https://510kreport.com/company/globus-medical