ImplaFit® Hip Stems

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

Implantcast, GmbH

The following data is part of a premarket notification filed by Implantcast, Gmbh with the FDA for Implafit® Hip Stems.

Pre-market Notification Details

• Device ID: K210678
• 510k Number: K210678
• Device Name: ImplaFit® Hip Stems
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: implantcast, GmbH Luneburger Schanze 26 21614 Buxtehude, DE
• Contact: Juliane Hoppner
• Correspondent: Dave McGurl; MCRA,LLC. 1050 K Street NW, Suite 1000 Washington, DC 20001
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: KWY
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-05
• Decision Date: 2022-08-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048844477226	K210678	000
04048844477110	K210678	000
04048844477127	K210678	000
04048844477134	K210678	000
04048844477141	K210678	000
04048844477158	K210678	000
04048844477165	K210678	000
04048844477172	K210678	000
04048844477189	K210678	000
04048844477196	K210678	000
04048844477202	K210678	000
04048844477219	K210678	000
04048844477080	K210678	000