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510(k) K232425

Device
Signature? ONE System
Applicant
Orthosoft Inc. (D/B/A) Zimmer Cas)
510(k) number
K232425
Product code
QHE
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-12
Date received
2023-08-11
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
No

Applicant Contact#

Contact
Nilam Dave
Address
75 Queen St. Suite 3300 Montreal CA H3C 2N6 H3C 2N6

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QHE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-02-04
K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.2026-01-12
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
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
K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.2022-12-20