G7 Freedom And Offset Liners, Freedom Head, Size 32

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

Biomet, Inc.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for G7 Freedom And Offset Liners, Freedom Head, Size 32.

Pre-market Notification Details

• Device ID: K142882
• 510k Number: K142882
• Device Name: G7 Freedom And Offset Liners, Freedom Head, Size 32
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581
• Contact: Becky Earl
• Correspondent: Becky Earl; Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581
• 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: 2014-10-02
• Decision Date: 2015-02-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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