NOVATION 12/14 PRESS-FIT FEMORAL STEM

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

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation 12/14 Press-fit Femoral Stem.

Pre-market Notification Details

• Device ID: K042842
• 510k Number: K042842
• Device Name: NOVATION 12/14 PRESS-FIT FEMORAL STEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Lisa Simpson
• Correspondent: Lisa Simpson; EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: LWJ
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-14
• Decision Date: 2004-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885862033468	K042842	000
10885862034205	K042842	000
10885862034199	K042842	000
10885862034182	K042842	000
10885862034175	K042842	000
10885862034168	K042842	000
10885862034151	K042842	000
10885862034144	K042842	000
10885862034137	K042842	000
10885862034120	K042842	000
10885862034113	K042842	000
10885862034212	K042842	000
10885862034229	K042842	000
10885862033413	K042842	000
10885862034311	K042842	000
10885862034304	K042842	000
10885862034298	K042842	000
10885862034281	K042842	000
10885862034274	K042842	000
10885862034267	K042842	000
10885862034250	K042842	000
10885862034243	K042842	000
10885862034236	K042842	000
10885862034106	K042842	000
10885862034090	K042842	000
10885862033949	K042842	000
10885862033932	K042842	000
10885862033925	K042842	000
10885862033918	K042842	000
10885862033901	K042842	000
10885862033895	K042842	000
10885862033888	K042842	000
10885862033871	K042842	000
10885862033864	K042842	000
10885862033857	K042842	000
10885862033956	K042842	000
10885862033963	K042842	000
10885862034083	K042842	000
10885862034076	K042842	000
10885862034069	K042842	000
10885862034052	K042842	000
10885862034045	K042842	000
10885862034038	K042842	000
10885862034007	K042842	000
10885862033994	K042842	000
10885862033987	K042842	000
10885862033970	K042842	000
10885862033215	K042842	000
10885862033659	K042842	000
10885862033185	K042842	000
10885862220400	K042842	000
10885862220394	K042842	000
10885862034021	K042842	000
10885862033796	K042842	000
10885862033789	K042842	000
10885862033772	K042842	000
10885862033765	K042842	000
10885862033758	K042842	000
10885862033741	K042842	000
10885862033192	K042842	000
10885862033208	K042842	000
10885862033581	K042842	000
10885862033451	K042842	000
10885862033444	K042842	000
10885862033437	K042842	000
10885862033420	K042842	000
10885862033406	K042842	000
10885862033390	K042842	000
10885862033376	K042842	000
10885862033369	K042842	000
10885862033253	K042842	000
10885862033734	K042842	000
10885862033727	K042842	000
10885862033574	K042842	000
10885862033567	K042842	000
10885862033550	K042842	000
10885862033543	K042842	000
10885862033536	K042842	000
10885862033529	K042842	000
10885862033512	K042842	000
10885862033505	K042842	000
10885862033499	K042842	000
10885862033482	K042842	000
10885862033598	K042842	000
10885862033604	K042842	000
10885862033710	K042842	000
10885862033703	K042842	000
10885862033697	K042842	000
10885862033680	K042842	000
10885862033673	K042842	000
10885862033666	K042842	000
10885862033642	K042842	000
10885862033635	K042842	000
10885862033628	K042842	000
10885862033611	K042842	000
10885862033475	K042842	000