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-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biomet Spine with 37 510(k) clearances and 14 device recalls. The most recent is a 510(k) clearance dated Jul 8, 2016: Alta ACDF System.
| Jul 8, 2016 | Alta ACDF SystemK152622 · OVE | 510(k) clearances |
| Jan 21, 2016 | Biomet Spine Fusion SystemK153695 · MAX | 510(k) clearances |
| Nov 13, 2015 | Polaris Spinal SystemK151974 · NKB | 510(k) clearances |
| Aug 12, 2015 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion SystemK151064 · OVE | 510(k) clearances |
| Jul 31, 2015 | Biomet Spine Fusion SystemK151483 · MAX | 510(k) clearances |
| Jun 30, 2015 | Lineum OCT Spine SystemK151224 · NKG | 510(k) clearances |
| Mar 12, 2015 | Biomet Spine Fusion SystemK142634 · MAX | 510(k) clearances |
| Nov 5, 2014 | MAXAN ANTERIOR CERVICAL PLATE SYSTEMK133518 · KWQ | 510(k) clearances |
| Mar 9, 2011 | LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spClass II · Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially | Device recalls |
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
