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FDA 510(k)

EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT

K-Number: K121220 · 2012-11-20

ApplicantExactech, Inc.
Decision Date2012-11-20
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K121220. 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 EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT?

EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Exactech, Inc.. The 510(k) number is K121220.

When did EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT receive FDA 510(k) clearance?

EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT received FDA 510(k) clearance on 2012-11-20, under 510(k) number K121220.

Who is the listed applicant for EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT?

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

What is the FDA product code for EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT?

The FDA product code for EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT is KWS.

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Other records listing Exactech, 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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