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FDA 510(k)

CAS PSI SHOULDER

K-Number: K131129 · 2013-08-20

ApplicantZimmer Cas
Decision Date2013-08-20
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAS PSI SHOULDER is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Cas. It received FDA 510(k) clearance on 2013-08-20 under 510(k) number K131129. 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 CAS PSI SHOULDER?

CAS PSI SHOULDER is a medical device that received FDA 510(k) clearance on 2013-08-20. The listed applicant is Zimmer Cas. The 510(k) number is K131129.

When did CAS PSI SHOULDER receive FDA 510(k) clearance?

CAS PSI SHOULDER received FDA 510(k) clearance on 2013-08-20, under 510(k) number K131129.

Who is the listed applicant for CAS PSI SHOULDER?

The FDA 510(k) record lists Zimmer Cas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAS PSI SHOULDER?

The FDA product code for CAS PSI SHOULDER is KWS.

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Other records listing Zimmer Cas 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.

K110054NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE

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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