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FDA 510(k)

MODULAR HYBRID GLENOID

K-Number: K060694 · 2006-12-11

ApplicantBiomet Manufacturing Corp
Decision Date2006-12-11
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULAR HYBRID GLENOID is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2006-12-11 under 510(k) number K060694. 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 MODULAR HYBRID GLENOID?

MODULAR HYBRID GLENOID is a medical device that received FDA 510(k) clearance on 2006-12-11. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K060694.

When did MODULAR HYBRID GLENOID receive FDA 510(k) clearance?

MODULAR HYBRID GLENOID received FDA 510(k) clearance on 2006-12-11, under 510(k) number K060694.

Who is the listed applicant for MODULAR HYBRID GLENOID?

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

What is the FDA product code for MODULAR HYBRID GLENOID?

The FDA product code for MODULAR HYBRID GLENOID is KWS.

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Other records listing Biomet Manufacturing Corp 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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