FDA.reportPublic FDA data

510(k) K202454

Device
Smart SPACE Shoulder System
Applicant
Techmah Medical, LLC
510(k) number
K202454
Product code
QHE
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-28
Date received
2020-08-27
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
Mohamed R. Mahfouz
Address
2099 Thunderhead Rd., Suite 302 Knoxville TN US 37922 37922

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QHE#

510(k), Device, Applicant table
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K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.2024-10-02
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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