Libertas – Taper Uncemented Femoral Stem

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

Maxx Orthopedics Inc.

The following data is part of a premarket notification filed by Maxx Orthopedics Inc. with the FDA for Libertas – Taper Uncemented Femoral Stem.

Pre-market Notification Details

• Device ID: K183684
• 510k Number: K183684
• Device Name: Libertas – Taper Uncemented Femoral Stem
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Maxx Orthopedics Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403
• Contact: Priscilla Herpai
• Correspondent: Priscilla Herpai; Maxx Orthopedics Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-28
• Decision Date: 2019-08-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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