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 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Amendia with 16 510(k) clearances and 12 device recalls. The most recent is a device recall dated Nov 13, 2017: Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical ….
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.
| Date | Record | Source |
|---|---|---|
| Nov 13, 2017 | Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization ofClass II · Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 | Device recalls |
| Nov 8, 2016 | Amendia Interbody Fusion DevicesK160924 · MAX | 510(k) clearances |
| Oct 13, 2016 | Overwatch Spine SystemK161842 · NKB | 510(k) clearances |
| Jul 8, 2016 | Savannah-T® Pedicle Screw SystemK152920 · NKB | 510(k) clearances |
| Apr 27, 2016 | Syzygy Stabilization SystemK153152 · NKB | 510(k) clearances |
| Feb 18, 2016 | Optimus ALIF SystemK160291 · OVD | 510(k) clearances |
| Jan 14, 2016 | Amendia Stand-Alone Cervical SystemK152972 · OVE | 510(k) clearances |
| Jan 6, 2016 | Amendia Interbody Fusion DevicesK151310 · MAX | 510(k) clearances |
| Dec 22, 2015 | Rectangular Corpectomy CageK152460 · MQP | 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
