Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Smart SPACE Shoulder System

K-Number: K202454 · 2020-12-28

ApplicantTechmah Medical, LLC
Decision Date2020-12-28
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smart SPACE Shoulder System is a medical device manufactured by Techmah Medical, LLC. It received FDA 510(k) clearance on 2020-12-28 under approval number K202454. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart SPACE Shoulder System?

Smart SPACE Shoulder System is a medical device that received FDA 510(k) clearance on 2020-12-28. It is manufactured by Techmah Medical, LLC. The 510(k) number is K202454.

When was Smart SPACE Shoulder System approved by the FDA?

Smart SPACE Shoulder System received FDA 510(k) clearance on 2020-12-28, under approval number K202454.

What company makes Smart SPACE Shoulder System?

Smart SPACE Shoulder System is manufactured by Techmah Medical, LLC.

What is the FDA product code for Smart SPACE Shoulder System?

The FDA product code for Smart SPACE Shoulder System is QHE.

Related Clinical Trials

NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING NCT07579832 Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2 NOT_YET_RECRUITING NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Techmah Medical, LLC

K191247SmartSPACE Shoulder System K202151Smart SPACE Shoulder System

Related Devices (Code: QHE)

K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerMaterialise NV K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202151Smart SPACE Shoulder SystemTechmah Medical, LLC K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑