TAPERLOC COMPLETE

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Taperloc Complete.

Pre-market Notification Details

• Device ID: K101086
• 510k Number: K101086
• Device Name: TAPERLOC COMPLETE
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Contact: Gary Baker
• Correspondent: Gary Baker; BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587
• Product Code: KWA
• Subsequent Product Code: JDI
• Subsequent Product Code: JDL
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: MAY
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-04-19
• Decision Date: 2010-09-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304499188	K101086	000
00880304498341	K101086	000
00880304498334	K101086	000
00880304498297	K101086	000
00880304498280	K101086	000
00880304498273	K101086	000
00880304498266	K101086	000
00880304498259	K101086	000
00880304498242	K101086	000
00880304498235	K101086	000
00880304498228	K101086	000
00880304498211	K101086	000
00880304498358	K101086	000
00880304498365	K101086	000
00880304498372	K101086	000
00880304499171	K101086	000
00880304499164	K101086	000
00880304499157	K101086	000
00880304499140	K101086	000
00880304499133	K101086	000
00880304499126	K101086	000
00880304499119	K101086	000
00880304499102	K101086	000
00880304499096	K101086	000
00880304499089	K101086	000
00880304498389	K101086	000
00880304498204	K101086	000
00880304498198	K101086	000
00880304498181	K101086	000
00880304489691	K101086	000
00880304489684	K101086	000
00880304489677	K101086	000
00880304489660	K101086	000
00880304489653	K101086	000
00880304489646	K101086	000
00880304481046	K101086	000
00880304481022	K101086	000
00887868508264	K101086	000
00887868508240	K101086	000
00887868508417	K101086	000
00880304489707	K101086	000
00880304489714	K101086	000
00880304489721	K101086	000
00880304491861	K101086	000
00880304491854	K101086	000
00880304491847	K101086	000
00880304491830	K101086	000
00880304491823	K101086	000
00880304491816	K101086	000
00880304489776	K101086	000
00880304489769	K101086	000
00880304489752	K101086	000
00880304489745	K101086	000
00880304489738	K101086	000
00887868508400	K101086	000
00880304499195	K101086	000
00880304989191	K101086	000
00880304632486	K101086	000
00880304632479	K101086	000
00880304632462	K101086	000
00880304632455	K101086	000
00880304632448	K101086	000
00880304632431	K101086	000
00880304632424	K101086	000
00880304632417	K101086	000
00880304632400	K101086	000
00880304632394	K101086	000
00880304632387	K101086	000
00880304632493	K101086	000
00880304632509	K101086	000
00880304632516	K101086	000
00880304989184	K101086	000
00880304907416	K101086	000
00880304632608	K101086	000
00880304632592	K101086	000
00880304632585	K101086	000
00880304632578	K101086	000
00880304632561	K101086	000
00880304632554	K101086	000
00880304632547	K101086	000
00880304632530	K101086	000
00880304632523	K101086	000
00880304632370	K101086	000
00880304632363	K101086	000
00880304632226	K101086	000
00880304506855	K101086	000
00880304506831	K101086	000
00880304506824	K101086	000
00880304506817	K101086	000
00880304506800	K101086	000
00880304506794	K101086	000
00880304499294	K101086	000
00880304499287	K101086	000
00880304499270	K101086	000
00880304499263	K101086	000
00880304499256	K101086	000
00880304506879	K101086	000
00880304506893	K101086	000
00880304506909	K101086	000
00880304632219	K101086	000
00880304632202	K101086	000
00880304632196	K101086	000
00880304632172	K101086	000
00880304632165	K101086	000
00880304632158	K101086	000
00880304632141	K101086	000
00880304632134	K101086	000
00880304632127	K101086	000
00880304632110	K101086	000
00880304506923	K101086	000
00880304499249	K101086	000