Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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: K202151 · 2021-02-03

ApplicantTechmah Medical, LLC
Decision Date2021-02-03
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smart SPACE Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Techmah Medical, LLC. It received FDA 510(k) clearance on 2021-02-03 under 510(k) 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. The listed applicant is Techmah Medical, LLC. The 510(k) number is K202151.

When did Smart SPACE Shoulder System receive FDA 510(k) clearance?

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

Who is the listed applicant for Smart SPACE Shoulder System?

The FDA 510(k) record lists Techmah Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Techmah Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202454Smart SPACE Shoulder SystemK191247SmartSPACE Shoulder System

Related Devices (Code: QHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NVK261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Archer PSI System3D-SideK241470CORE Shoulder SystemLinkBio Corp.

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.

↑