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Software For Diagnosis/Treatment
FDA product code OSN · Class 2 · Orthopedic
451
Registered devices
22
Adverse events
2
Recalls
4
510(k) clearances
Devices with this code
NA — Synthes GmbHNA — Synthes GmbHNA — Synthes GmbHNA — Synthes GmbHSmart Correction — Wishbone Medical, Inc.NA — Synthes GmbHNA — Synthes GmbHMAXFRAME — Synthes GmbHArthrex® — ARTHREX, INC.NA — Synthes GmbHAcute QC Strut and Components — Smith & Nephew, Inc.Arthrex® — ARTHREX, INC.NA — Synthes GmbHMAXFRAME — Synthes GmbHNA — Synthes GmbHNA — Synthes GmbHAcute QC Strut and Components — Smith & Nephew, Inc.NA — Synthes GmbHNA — Synthes GmbHAcute QC Strut and Components — Smith & Nephew, Inc.NA — Synthes GmbHNA — Synthes GmbHNA — Synthes GmbHNA — Synthes GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-12 | OrthoPediatrics Corp | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruptio |
| 2017-12-13 | Smith & Nephew, Inc. | In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame wil |
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