FDA.report

510(k) K222405

Device
Smart SPACE Shoulder Planner and 3D Positioners
Applicant
Lima Corporate S.P.A.
510(k) number
K222405
Product code
QHE
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-20
Date received
2022-08-09
Regulation
888.3660
Classification name
Shoulder Arthroplasty Implantation System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Francesca Marello
Address
Via Nazionale 52 Villanova Di San Daniele Del Friuli IT 33038 33038

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
08033390248570Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390239516Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390239509Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390237024Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390237017Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390237000Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390236997Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390201957Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390201933Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390201919Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390201896Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390201872Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18
08033390201858Smart SPACE SHOULDERLIMACORPORATE SPA2023-02-18

Other 510(k) Records For Product Code QHE

510(k)DeviceApplicantDecision date
K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-02-04
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K243509Archer PSI System3D-Side2025-05-12
K241470CORE Shoulder SystemLinkBio Corp.2025-02-20
K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.2025-01-21
K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV2024-10-18
K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.2024-10-02
K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.2024-08-05
K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV2024-05-22
K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)2023-12-12
K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV2023-11-09
K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV2023-09-12
K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.2023-06-22
K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.2023-03-08
K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerMaterialise NV2023-03-06