EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids Tm.

Pre-market Notification Details

• Device ID: K103419
• 510k Number: K103419
• Device Name: EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: EXACTECH, INC. 2320 N.W. 66TH COURT Gainesville, FL 32653
• Contact: Patrick Hughes
• Correspondent: Patrick Hughes; EXACTECH, INC. 2320 N.W. 66TH COURT Gainesville, FL 32653
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-22
• Decision Date: 2010-12-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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