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 MedShape, Inc. with 17 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Sep 23, 2026: DynaNail Helix® Fixation 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.
| Sep 23, 2026 | DynaNail Helix® Fixation SystemK260995 · HWC | 510(k) clearances |
| Mar 18, 2026 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroK254110 · HWC | 510(k) clearances |
| Sep 12, 2025 | DynaNail TTC Fusion SystemK250628 · HSB | 510(k) clearances |
| Jun 2, 2025 | Medshape Universal Joints, REF: DNE-9000-UJClass II · Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this | Device recalls |
| Mar 21, 2024 | DynaNail Mini Tapered HybridK240530 · HWC | 510(k) clearances |
| Aug 19, 2022 | DynaClip® Bone StapleK220812 · JDR | 510(k) clearances |
| Jan 4, 2022 | DynaFuse Fixation SystemK203595 · HWC | 510(k) clearances |
| Nov 17, 2021 | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, SterileClass II · The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indica | Device recalls |
| Jan 15, 2021 | Dynanail Mini HybridK203381 · HWC | 510(k) clearances |
| Apr 23, 2020 | DynaClip Bone StapleK193305 · JDR | 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
