FDA Device Intelligence
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Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

FDA product code KTW · Class 2 · Orthopedic

992
Registered devices
916
Adverse events
57
Recalls
38
510(k) clearances

Devices with this code

Small Bone Phantom Intramedullary Nail System — Paragon 28, Inc.NA — SYNTHES (U.S.A.) LPNA — Synthes GmbHNA — Synthes GmbHCANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.Leforte System Bone Plate — Jeil Medical CorporationMATTA — Stryker GmbHLC-DCP — Synthes GmbHLeforte System Bone Plate — Jeil Medical CorporationNA — Synthes GmbHSmall Bone Phantom Intramedullary Nail System — Paragon 28, Inc.AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.NA — Synthes GmbHSmall Bone Phantom Intramedullary Nail System — Paragon 28, Inc.Small Bone Phantom Intramedullary Nail System — Paragon 28, Inc.Leforte System Bone Plate — Jeil Medical CorporationNA — SYNTHES (U.S.A.) LPNA — Synthes GmbHLCP — SYNTHES (U.S.A.) LPNA — Synthes GmbHNA — Synthes GmbHContours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate — ORTHOFIX SRLSmall Bone Phantom Intramedullary Nail System — Paragon 28, Inc.NA — SYNTHES (U.S.A.) LP

Recent recalls

DateFirmReason
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.
2010-10-27Synthes USA (HQ), Inc.Potential for out of specification star grind teeth.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.