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FDA 510(k)

SmartSPACE Shoulder System

K-Number: K191247 · 2019-11-15

ApplicantTechmah Medical, LLC
Decision Date2019-11-15
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SmartSPACE Shoulder System is a medical device manufactured by Techmah Medical, LLC. It received FDA 510(k) clearance on 2019-11-15 under approval number K191247. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartSPACE Shoulder System?

SmartSPACE Shoulder System is a medical device that received FDA 510(k) clearance on 2019-11-15. It is manufactured by Techmah Medical, LLC. The 510(k) number is K191247.

When was SmartSPACE Shoulder System approved by the FDA?

SmartSPACE Shoulder System received FDA 510(k) clearance on 2019-11-15, under approval number K191247.

What company makes SmartSPACE Shoulder System?

SmartSPACE Shoulder System is manufactured by Techmah Medical, LLC.

What is the FDA product code for SmartSPACE Shoulder System?

The FDA product code for SmartSPACE Shoulder System is KWS.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_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

K202454Smart SPACE Shoulder System K202151Smart SPACE Shoulder System

Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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.

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