ENDO HEAD

Prosthesis, Hip, Hemi-, Femoral, Metal Ball

MEDACTA INTERNATIONAL

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

Pre-market Notification Details

• Device ID: K111145
• 510k Number: K111145
• Device Name: ENDO HEAD
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal Ball
• Applicant: MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Contact: Adam Gross
• Correspondent: Adam Gross; MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012
• Product Code: LZY
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-22
• Decision Date: 2011-08-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630030806209	K111145	000
07630030806346	K111145	000
07630030806353	K111145	000
07630030806360	K111145	000
07630030806377	K111145	000
07630030806384	K111145	000
07630030806391	K111145	000
07630030806407	K111145	000
07630030806414	K111145	000
07630030806421	K111145	000
07630030806438	K111145	000
07630030806339	K111145	000
07630030806322	K111145	000
07630030806315	K111145	000
07630030806216	K111145	000
07630030806223	K111145	000
07630030806230	K111145	000
07630030806247	K111145	000
07630030806254	K111145	000
07630030806261	K111145	000
07630030806278	K111145	000
07630030806285	K111145	000
07630030806292	K111145	000
07630030806308	K111145	000
07630030806445	K111145	000
07630030806452	K111145	000
07630030806469	K111145	000
07630030806605	K111145	000
07630030806612	K111145	000
07630030806629	K111145	000
07630030806636	K111145	000
07630030806643	K111145	000
07630030806650	K111145	000
07630030806667	K111145	000
07630030806674	K111145	000
07630030806681	K111145	000
07630030806698	K111145	000
07630030806599	K111145	000
07630030806582	K111145	000
07630030806575	K111145	000
07630030806476	K111145	000
07630030806483	K111145	000
07630030806490	K111145	000
07630030806506	K111145	000
07630030806513	K111145	000
07630030806520	K111145	000
07630030806537	K111145	000
07630030806544	K111145	000
07630030806551	K111145	000
07630030806568	K111145	000
07630030806704	K111145	000