# Ldr Spine USA

- Location (FDA's records): Austin, TX
- FDA decisions: 35 (2005–2017): 35 510(k) clearances
- Names in FDA's records: Ldr Spine USA (25); Ldr Spine USA, Inc. (10)
- Product codes: MQP (8), MNI (5), OVD (4), NKB (3), MAX (3), MQV (2), MRW (2), OVE (2), ODP (2), KWP (1), MNH (1), PEK (1)
- 510(k) review time since 2016: median 155 days, against 124 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 80 (48 its own); citations of its devices by later devices: 171 (48 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
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- X-Spine Systems, Inc.: 2 (https://510kreport.com/company/x-spine-systems)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Ebi, L.P.: 2 (https://510kreport.com/company/ebi)
- Centinel Spine, Inc.: 2 (https://510kreport.com/company/centinel-spine)
- U&I Corporation: 2 (https://510kreport.com/company/u-i)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- Trans1 Incorporated: 1 (https://510kreport.com/company/trans1)

## Firms that cite its devices most
- Genesys Spine: 8 (https://510kreport.com/company/genesys-spine)
- Zavation, LLC: 4 (https://510kreport.com/company/zavation)
- Exactech, Inc.: 4 (https://510kreport.com/company/exactech)
- Nexus Spine, LLC: 4 (https://510kreport.com/company/nexus-spine)
- Nanovis, LLC: 3 (https://510kreport.com/company/nanovis)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Neurostructures, Inc.: 3 (https://510kreport.com/company/neurostructures)

## Its most-cited devices
- K091088: LDR Spine Cervical Interbody Fusion System (2009), cited by 51
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants (2011), cited by 21
- K043479: MC+ Partial VBR (2005), cited by 18
- K082262: LDR Spine Roi Interbody Fusion System (2009), cited by 8
- K150765: LDR Spine ROI-C Cervical Cage System (2015), cited by 7
- K043094: Easyspine System (2005), cited by 6

## Recent decisions
- K162133: VerteFIT Corpectomy Cage System (May 16, 2017)
- K161173: Avenue® T TLIF Cage (Sep 28, 2016)
- K161798: FacetBRIDGE® System (Aug 4, 2016)
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (Mar 31, 2016)
- K152137: FacetBRIDGE System (Jan 25, 2016)
- K151934: ROI-C Titanium-Coated Implant System (Dec 7, 2015)
- K150765: LDR Spine ROI-C Cervical Cage System (Sep 17, 2015)
- K142645: Avenue T TLIF Cage (Jun 11, 2015)

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