Zimmer Biomet 12/14 CoCr Femoral Head And Freedom Head

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Biomet 12/14 Cocr Femoral Head And Freedom Head.

Pre-market Notification Details

• Device ID: K183457
• 510k Number: K183457
• Device Name: Zimmer Biomet 12/14 CoCr Femoral Head And Freedom Head
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581 -0708
• Contact: Rebecca Nofiz
• Correspondent: Dean Heit; ZimmerBiomet Waterton Ind Estate Bridgend, GB Cf31 3xa
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWZ
• Subsequent Product Code: LZO
• Subsequent Product Code: OQG
• Subsequent Product Code: OQH
• Subsequent Product Code: OQI
• Subsequent Product Code: PBI
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-13
• Decision Date: 2019-11-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024625839	K183457	000
00889024498877	K183457	000
00889024498884	K183457	000
00889024498891	K183457	000
00889024498907	K183457	000
00889024498914	K183457	000
00889024498921	K183457	000
00889024498938	K183457	000
00889024498945	K183457	000
00889024498952	K183457	000
00889024498969	K183457	000
00889024498976	K183457	000
00889024498983	K183457	000
00889024498860	K183457	000
00889024498853	K183457	000
00889024625846	K183457	000
00889024498747	K183457	000
00889024498754	K183457	000
00889024498761	K183457	000
00889024498778	K183457	000
00889024498785	K183457	000
00889024498792	K183457	000
00889024498808	K183457	000
00889024498815	K183457	000
00889024498822	K183457	000
00889024498839	K183457	000
00889024498846	K183457	000
00889024498990	K183457	000
00889024499003	K183457	000
00889024499010	K183457	000
00889024499379	K183457	000
00889024499416	K183457	000
00889024499430	K183457	000
00889024499447	K183457	000
00889024499454	K183457	000
00889024499461	K183457	000
00889024499478	K183457	000
00889024499485	K183457	000
00889024499492	K183457	000
00889024499508	K183457	000
00889024499515	K183457	000
00889024499522	K183457	000
00889024499317	K183457	000
00889024499256	K183457	000
00889024499027	K183457	000
00889024499034	K183457	000
00889024499041	K183457	000
00889024499058	K183457	000
00889024499065	K183457	000
00889024499072	K183457	000
00889024499089	K183457	000
00889024499096	K183457	000
00889024499102	K183457	000
00889024499119	K183457	000
00889024499126	K183457	000
00889024499195	K183457	000
00889024499539	K183457	000