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FDA 510(k)

Smart SPACE Shoulder System

K-Number: K202151 · 2021-02-03

ApplicantTechmah Medical, LLC
Decision Date2021-02-03
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 2021-02-03 under approval number K202151. 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 2021-02-03. It is manufactured by Techmah Medical, LLC. The 510(k) number is K202151.

When was Smart SPACE Shoulder System approved by the FDA?

Smart SPACE Shoulder System received FDA 510(k) clearance on 2021-02-03, under approval number K202151.

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.

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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 K202454Smart SPACE Shoulder System

Related Devices (Code: QHE)

K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202454Smart SPACE Shoulder SystemTechmah Medical, LLC 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) 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.

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