Incipio Devices
Huntington, IN, US
INCIPIO DEVICES appears in FDA device records in Huntington, IN. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011015572 | 3011015572 | INCIPIO DEVICES | 3650 West 200 North, Huntington, IN 46750 US | 2026 | and 28 more, listed in full below |
| 3013223655 | 3013223655 | Incipio Devices SA | Av. des Paquiers 16, St Blaise Neuchatel 2072 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXDClamp
- HWBExtractor
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HAWNeurological Stereotaxic Instrument
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- HWMOsteotome
- HRSPlate, Fixation, Bone
- HXBProbe
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- JDCProsthesis, Elbow, Constrained, Cemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- HTOReamer
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- PHXShoulder Prosthesis, Reverse Configuration
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0549-2025 | Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants. | Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain