E-POLY TIBIAL BEARINGS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

BIOMET ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for E-poly Tibial Bearings.

Pre-market Notification Details

• Device ID: K080528
• 510k Number: K080528
• Device Name: E-POLY TIBIAL BEARINGS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Melissa Steinwedel
• Correspondent: Melissa Steinwedel; BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: JWH
• Subsequent Product Code: MBH
• Subsequent Product Code: MBV
• Subsequent Product Code: OIY
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-26
• Decision Date: 2008-06-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304466289	K080528	000
00880304466098	K080528	000
00880304466081	K080528	000
00880304466074	K080528	000
00880304466067	K080528	000
00880304466050	K080528	000
00880304466043	K080528	000
00880304466036	K080528	000
00880304466029	K080528	000
00880304466012	K080528	000
00880304466005	K080528	000
00880304465992	K080528	000
00880304465985	K080528	000
00880304465978	K080528	000
00880304465961	K080528	000
00880304465954	K080528	000
00880304466104	K080528	000
00880304466111	K080528	000
00880304466128	K080528	000
00880304466272	K080528	000
00880304466265	K080528	000
00880304466258	K080528	000
00880304466241	K080528	000
00880304466234	K080528	000
00880304466227	K080528	000
00880304466210	K080528	000
00880304466203	K080528	000
00880304466197	K080528	000
00880304466180	K080528	000
00880304466173	K080528	000
00880304466166	K080528	000
00880304466159	K080528	000
00880304466142	K080528	000
00880304466135	K080528	000
00880304465947	K080528	000
00880304465930	K080528	000
00880304465749	K080528	000
00880304465732	K080528	000
00880304465725	K080528	000
00880304465718	K080528	000
00880304465701	K080528	000
00880304465695	K080528	000
00880304465688	K080528	000
00880304465671	K080528	000
00880304465664	K080528	000
00880304465657	K080528	000
00880304465640	K080528	000
00880304465633	K080528	000
00880304465626	K080528	000
00880304465619	K080528	000
00880304465602	K080528	000
00880304465756	K080528	000
00880304465763	K080528	000
00880304465770	K080528	000
00880304465923	K080528	000
00880304465916	K080528	000
00880304465909	K080528	000
00880304465893	K080528	000
00880304465886	K080528	000
00880304465879	K080528	000
00880304465862	K080528	000
00880304465855	K080528	000
00880304465848	K080528	000
00880304465831	K080528	000
00880304465824	K080528	000
00880304465817	K080528	000
00880304465800	K080528	000
00880304465794	K080528	000
00880304465787	K080528	000
00880304465596	K080528	000
00880304648432	K080528	000
00880304541092	K080528	000
00880304541085	K080528	000
00880304541078	K080528	000
00880304541061	K080528	000
00880304541054	K080528	000
00880304541047	K080528	000
00880304541030	K080528	000
00880304541023	K080528	000
00880304541016	K080528	000
00880304541009	K080528	000
00880304540965	K080528	000
00880304480018	K080528	000
00880304480001	K080528	000
00880304479999	K080528	000
00880304479982	K080528	000
00880304541108	K080528	000
00880304541115	K080528	000
00880304541122	K080528	000
00880304648425	K080528	000
00880304648418	K080528	000
00880304648395	K080528	000
00880304648371	K080528	000
00880304648241	K080528	000
00880304648234	K080528	000
00880304648227	K080528	000
00880304648203	K080528	000
00880304648180	K080528	000
00880304545762	K080528	000
00880304545755	K080528	000
00880304545748	K080528	000
00880304545731	K080528	000
00880304545724	K080528	000
00880304541139	K080528	000
00880304479975	K080528	000
00880304476776	K080528	000
00880304473119	K080528	000
00880304473102	K080528	000
00880304473096	K080528	000
00880304473089	K080528	000
00880304473072	K080528	000
00880304473058	K080528	000
00880304473041	K080528	000
00880304473034	K080528	000
00880304473027	K080528	000
00880304473010	K080528	000
00880304473003	K080528	000
00880304472990	K080528	000
00880304472983	K080528	000
00880304472891	K080528	000
00880304472884	K080528	000
00880304473126	K080528	000
00880304473133	K080528	000
00880304473140	K080528	000
00880304476769	K080528	000
00880304476752	K080528	000
00880304476745	K080528	000
00880304476738	K080528	000
00880304476721	K080528	000
00880304476714	K080528	000
00880304476707	K080528	000
00880304476691	K080528	000
00880304473232	K080528	000
00880304473225	K080528	000
00880304473218	K080528	000
00880304473201	K080528	000
00880304473195	K080528	000
00880304473164	K080528	000
00880304473157	K080528	000
00880304472747	K080528	000