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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 the device name listed in this FDA 510(k) record. The listed applicant is Techmah Medical, LLC. It received FDA 510(k) clearance on 2019-11-15 under 510(k) 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. The listed applicant is Techmah Medical, LLC. The 510(k) number is K191247.

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

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

Who is the listed applicant for SmartSPACE 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 SmartSPACE Shoulder System?

The FDA product code for SmartSPACE Shoulder System is KWS.

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.

K202151Smart SPACE Shoulder SystemK202454Smart SPACE Shoulder System

Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

Official Source

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

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