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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list ChoiceSpine with 26 510(k) clearances. The most recent is a 510(k) clearance dated May 1, 2019: Boomerang™ Anterior Cervical Plate 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 1, 2019 | Boomerang™ Anterior Cervical Plate SystemK190227 · KWQ | 510(k) clearances |
| Mar 6, 2019 | ChoiceSpine Stealth Cervical Spacer SystemK183397 · ODP | 510(k) clearances |
| Feb 22, 2019 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemK183588 · MQP | 510(k) clearances |
| Jan 8, 2019 | Choice Spine Navigation SystemK182721 · OLO | 510(k) clearances |
| Jan 3, 2019 | Raven Lumbar Plate SystemK183214 · KWQ | 510(k) clearances |
| May 16, 2018 | HARRIER-SA™ Lumbar Interbody SystemK180519 · OVD | 510(k) clearances |
| Jan 26, 2018 | TiGer Shark™ SystemK172816 · MAX | 510(k) clearances |
| Jan 19, 2018 | Choice Spine Laminoplasty™ Fixation SystemK173215 · NQW | 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
