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FDA 510(k)

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

K-Number: K241878 · 2024-12-06

ApplicantStryker Corporation (Tornier, Inc.)
Decision Date2024-12-06
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is a medical device manufactured by Stryker Corporation (Tornier, Inc.). It received FDA 510(k) clearance on 2024-12-06 under approval number K241878. 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 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Stryker Corporation (Tornier, Inc.). The 510(k) number is K241878.

When was Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) approved by the FDA?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) received FDA 510(k) clearance on 2024-12-06, under approval number K241878.

What company makes Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is manufactured by Stryker Corporation (Tornier, Inc.).

What is the FDA product code for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

The FDA product code for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is KWS.

Related Clinical Trials

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Other Devices by Stryker Corporation (Tornier, Inc.)

K241609Tornier Humeral Reconstruction System (Tornier HRS)

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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