Data / Medical devices / France / LDR Medical
LDR Medical: FDA-registered device maker in Sainte-Savine Aube, France, 37 510(k) clearances and 2 PMA approvals
LDR Medical is registered with the FDA (registration 3004788213) in Sainte-Savine Aube, France. It lists 37 device types. The FDA files 37 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 16, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004788213
- Address
- Parc dentreprises du Grande Troyes Quartier Europe de lOuest, 5 rue de Berlin, Sainte-Savine Aube, France, 10300
- Owner or operator
- Highridge Medical, LLC (9068198)
- Roles
- Specification developer
- First device listed
- February 18, 2005
- Registered through
- 2026
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2017 | K162133 | VerteFIT Corpectomy Cage System | MQP | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| September 28, 2016 | K161173 | Avenue® T TLIF Cage | OVD | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| August 4, 2016 | K161798 | FacetBRIDGE® System | MRW | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| March 31, 2016 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | MAX | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| January 25, 2016 | K152137 | FacetBRIDGE System | MRW | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| December 7, 2015 | K151934 | ROI-C Titanium-Coated Implant System | OVE | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| September 17, 2015 | K150765 | LDR Spine ROI-C Cervical Cage System | OVE | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| June 11, 2015 | K142645 | Avenue T TLIF Cage | OVD | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| March 7, 2014 | K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | PEK | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| February 1, 2013 | K123134 | EASYSPINE SYSTEM | NKB | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| August 24, 2012 | K121103 | LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S | NKB | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| July 26, 2012 | K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | OVD | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| June 27, 2012 | K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | MNH | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| December 29, 2011 | K113559 | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS | ODP | Substantially Equivalent | Ldr Spine USA, Inc. | accessdata.fda.gov |
| September 30, 2011 | K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | OVD | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| October 15, 2010 | K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM | MNI | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| September 29, 2010 | K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| March 31, 2010 | K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM | MNI | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| November 9, 2009 | K091725 | PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) | MNH | Substantially Equivalent | U&I Corp. | accessdata.fda.gov |
| July 14, 2009 | K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | ODP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| June 25, 2009 | K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM | MAX | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| February 12, 2009 | K083857 | LDR SPINE ROI-C IMPLANT | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| February 2, 2009 | K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| October 8, 2008 | K082592 | LDR SPINE EASYSPINE SYSTEM | NKB | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| May 29, 2008 | K080728 | LDR SPINE ROI-C IMPLANT | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| May 7, 2008 | K080569 | LDR SPINE ROI-T IMPLANT | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| April 7, 2008 | K080572 | LDR SPINE ROI-A IMPLANT | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| August 30, 2007 | K072132 | LDR SPINE ROI-T SYSTEM | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| August 8, 2007 | K070341 | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM | KWP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| January 24, 2007 | K063794 | MODIFICATION TO EASYSPINE SYSTEM | MNI | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| December 15, 2006 | K061462 | BF+ (PH) | MQV | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| November 15, 2006 | K061002 | MAXIMA ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | U&I Corp. | accessdata.fda.gov |
| August 10, 2006 | K061017 | EASYSPINE SYSTEM | MNI | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| June 30, 2005 | K043479 | MC+ PARTIAL VBR | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| June 29, 2005 | K043349 | OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) | MQP | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| February 11, 2005 | K043094 | EASYSPINE SYSTEM | MNI | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
| January 7, 2005 | K043347 | BF+ | MQV | Substantially Equivalent | Ldr Spine USA | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 23, 2013 | P110009 | MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) | MJO | 34 | September 16, 2026 | accessdata.fda.gov |
| August 7, 2013 | P110002 | MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) | MJO | 34 | September 16, 2026 | accessdata.fda.gov |
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Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.