Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list LDR Spine USA with 35 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 16, 2017: VerteFIT Corpectomy Cage System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 16, 2017 | VerteFIT Corpectomy Cage SystemK162133 · MQP | 510(k) clearances |
| Sep 28, 2016 | Avenue® T TLIF CageK161173 · OVD | 510(k) clearances |
| Aug 29, 2016 | ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-AClass II · The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-h | Device recalls |
| Aug 4, 2016 | FacetBRIDGE® SystemK161798 · MRW | 510(k) clearances |
| Mar 31, 2016 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemK153495 · MAX | 510(k) clearances |
| Jan 25, 2016 | FacetBRIDGE SystemK152137 · MRW | 510(k) clearances |
| Dec 7, 2015 | ROI-C Titanium-Coated Implant SystemK151934 · OVE | 510(k) clearances |
| Sep 17, 2015 | LDR Spine ROI-C Cervical Cage SystemK150765 · OVE | 510(k) clearances |
| Jun 11, 2015 | Avenue T TLIF CageK142645 · OVD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
