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
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