ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Arcomxl Polyethylene Liners And 38/40mm Femoral Heads.

Pre-market Notification Details

• Device ID: K062997
• 510k Number: K062997
• Device Name: ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Becky Earl
• Correspondent: Becky Earl; BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-10-02
• Decision Date: 2006-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868512148	K062997	000
00880304430822	K062997	000
00880304477643	K062997	000
00880304477650	K062997	000
00880304477674	K062997	000
00880304477681	K062997	000
00880304477841	K062997	000
00880304651197	K062997	000
00880304651203	K062997	000
00880304651210	K062997	000
00880304651227	K062997	000
00880304651333	K062997	000
00880304651340	K062997	000
00880304651357	K062997	000
00880304651364	K062997	000
00880304651371	K062997	000
00880304651388	K062997	000
00880304651395	K062997	000
00880304163706	K062997	000
00880304163539	K062997	000
00880304163522	K062997	000
00887868512155	K062997	000
00887868512162	K062997	000
00887868512179	K062997	000
00887868343018	K062997	000
00887868343025	K062997	000
00887868343032	K062997	000
00887868343049	K062997	000
00887868343056	K062997	000
00887868343063	K062997	000
00887868343070	K062997	000
00887868343087	K062997	000
00887868343186	K062997	000
00887868343193	K062997	000
00887868343209	K062997	000
00887868343216	K062997	000
00887868343223	K062997	000
00880304163416	K062997	000
00880304651401	K062997	000
00880304651418	K062997	000
00880304651425	K062997	000
00880304651951	K062997	000
00880304651968	K062997	000
00880304651975	K062997	000
00880304651982	K062997	000
00880304651999	K062997	000
00880304652002	K062997	000
00880304652019	K062997	000
00880304652026	K062997	000
00880304652033	K062997	000
00880304652040	K062997	000
00880304652057	K062997	000
00880304652064	K062997	000
00880304656383	K062997	000
00880304656390	K062997	000
00880304656406	K062997	000
00880304656413	K062997	000
00880304656420	K062997	000
00880304651944	K062997	000
00880304651937	K062997	000
00880304651920	K062997	000
00880304651432	K062997	000
00880304651449	K062997	000
00880304651456	K062997	000
00880304651463	K062997	000
00880304651630	K062997	000
00880304651647	K062997	000
00880304651654	K062997	000
00880304651821	K062997	000
00880304651838	K062997	000
00880304651845	K062997	000
00880304651852	K062997	000
00880304651869	K062997	000
00880304651876	K062997	000
00880304651883	K062997	000
00880304651890	K062997	000
00880304651906	K062997	000
00880304651913	K062997	000
00880304656437	K062997	000