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FDA 510(k)

GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID

K-Number: K092122 · 2009-07-27

ApplicantDePuy Orthopaedics, Inc.
Decision Date2009-07-27
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2009-07-27 under 510(k) number K092122. 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 GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID?

GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID is a medical device that received FDA 510(k) clearance on 2009-07-27. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K092122.

When did GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID receive FDA 510(k) clearance?

GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID received FDA 510(k) clearance on 2009-07-27, under 510(k) number K092122.

Who is the listed applicant for GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID?

The FDA product code for GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID is KWS.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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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

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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