Lima Corporate S.p.A.
Winona Lake, IN, US
Lima Corporate S.P.A. appears in FDA device records in Winona Lake, IN. FDA records list 64 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 64
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 64FDA records hold 64 510(k) clearances for Lima Corporate S.p.A. between 2011 and 2026. The busiest year on record is 2015, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 4 |
| 2012 | 5 |
| 2013 | 2 |
| 2014 | 5 |
| 2015 | 7 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 6 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 5 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | PHX | Substantially Equivalent | |
| K251718 | ArTT Augments and Buttresses and Bone Screws | LPH | Substantially Equivalent | |
| K243826 | SMR Reverse HP Shoulder System | PHX | Substantially Equivalent | |
| K250980 | Physica System (Physica CR Porous Femoral components) | MBH | Substantially Equivalent | |
| K243615 | Physica Porous Femoral Components | MBH | Substantially Equivalent | |
| K234011 | AMF TT Cones | JWH | Substantially Equivalent | |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | MBF | Substantially Equivalent | |
| K231099 | SMR Hybrid Glenoid System | MBF | Substantially Equivalent | |
| K231925 | MINIMA S System | LZO | Substantially Equivalent | |
| K221758 | SMR Stemless Anatomic | PKC | Substantially Equivalent | |
| K223876 | SMR Shoulder System | MBF | Substantially Equivalent | |
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | QHE | Substantially Equivalent | |
| K222807 | TEMA Elbow system - Line extension | JDB | Substantially Equivalent | |
| K222427 | PRIMA TT Glenoid | MBF | Substantially Equivalent | |
| K220792 | SMR Reverse Liner | MBF | Substantially Equivalent | |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | PHX | Substantially Equivalent | |
| K213381 | Physica system | JWH | Substantially Equivalent | |
| K210717 | Bone Screws dia. 5,0 mm | PHX | Substantially Equivalent | |
| K210554 | Physica system | MBH | Substantially Equivalent | |
| K203475 | LimaCorporate Kirschner Wire | HTY | Substantially Equivalent | |
| K201905 | SMR 140° Reverse Humeral Body | MBF | Substantially Equivalent | |
| K201084 | Physica system | MBH | Substantially Equivalent | |
| K200171 | SMR TT Augmented Glenoid System | PHX | Substantially Equivalent | |
| K200656 | Delta Multihole TT Pro Acetabular System | LPH | Substantially Equivalent | |
| K200653 | AMF Revision TT Cones | JWH | Substantially Equivalent | |
| K193284 | Physica LMC Knee System | JWH | Substantially Equivalent | |
| K191746 | SMR TT Augmented Glenoid System | PHX | Substantially Equivalent | |
| K191622 | Delta Multihole TT Pro Acetabular System | LPH | Substantially Equivalent | |
| K191963 | SMR Finned Short Stems | MBF | Substantially Equivalent | |
| K181491 | Delta Dual Mobility System | LZO | Substantially Equivalent | |
| K181362 | TEMA Elbow System | JDC | Substantially Equivalent | |
| K183042 | SMR Lateralized Connectors with screws | KWS | Substantially Equivalent | |
| K182099 | Delta TT Pro | LPH | Substantially Equivalent | |
| K172456 | Bone Screws 6.5mm | LPH | Substantially Equivalent | |
| K170473 | C2 femoral stem | LZO | Substantially Equivalent | |
| K163397 | SMR Hybrid Glenoid System | MBF | Substantially Equivalent | |
| K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments | PHX | Substantially Equivalent | |
| K161226 | Revision Femoral Stem | LZO | Substantially Equivalent | |
| K160011 | H-Max S stem | MEH | Substantially Equivalent | |
| K161476 | SMR Shoulder System | KWT | Substantially Equivalent | |
| K153722 | SMR 3-Pegs Glenoids | KWS | Substantially Equivalent | |
| K151739 | Revision Femoral Stem | LZO | Substantially Equivalent | |
| K152008 | Physica PS Knee System | JWH | Substantially Equivalent | |
| K150855 | H-MAX S Femoral Hip System | MEH | Substantially Equivalent | |
| K151266 | Physica CR Knee System | JWH | Substantially Equivalent | |
| K143256 | SMR Modular Glenoid | KWS | Substantially Equivalent | |
| K141934 | PHYSICA KR KNEE SYSTEM | JWH | Substantially Equivalent | |
| K143509 | MasterSL femoral stem | LZO | Substantially Equivalent | |
| K142139 | SMR 40MM GLENOSPHERE | PHX | Substantially Equivalent | |
| K141327 | MINIMA S SYSTEM | LZO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HTYPin, Fixation, Smooth
- JDCProsthesis, Elbow, Constrained, Cemented
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer 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
- QHEShoulder Arthroplasty Implantation System
- PHXShoulder Prosthesis, Reverse Configuration
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
