MiniMAX

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

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Minimax.

Pre-market Notification Details

• Device ID: K170845
• 510k Number: K170845
• Device Name: MiniMAX
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Elizabeth Rose; Mapi USA, Inc 2343 Alexandria Drive, Suite 100 Lexington, KY 40504
• Product Code: LZO
• Subsequent Product Code: KWY
• Subsequent Product Code: LZY
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-21
• Decision Date: 2017-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030803307	K170845	000
07630030803147	K170845	000
07630030803154	K170845	000
07630030803161	K170845	000
07630030803178	K170845	000
07630030803185	K170845	000
07630030803192	K170845	000
07630030803208	K170845	000
07630030803215	K170845	000
07630030803222	K170845	000
07630030803239	K170845	000
07630030803246	K170845	000
07630030803253	K170845	000
07630030803260	K170845	000
07630030803277	K170845	000
07630030803284	K170845	000
07630030803291	K170845	000
07630030803130	K170845	000