Remedy® Shoulder Spacer

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Osteoremedies LLC

The following data is part of a premarket notification filed by Osteoremedies Llc with the FDA for Remedy® Shoulder Spacer.

Pre-market Notification Details

• Device ID: K152267
• 510k Number: K152267
• Device Name: Remedy® Shoulder Spacer
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: Osteoremedies LLC 6800 Poplar Avenue Suite 120 Memphis, TN 38138
• Contact: Chris Hughes
• Correspondent: Diane Mandell Horwitz; Mandell Horwitz Consultants LLC 2995 Steven Martin Dr. Fairfax, VA 22031
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2015-08-11
• Decision Date: 2015-12-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855195006487	K152267	000
00855195006203	K152267	000
00855195006210	K152267	000
00855195006227	K152267	000
00855195006234	K152267	000
00855195006432	K152267	000
00855195006449	K152267	000
00855195006456	K152267	000
00855195006463	K152267	000
00855195006470	K152267	000
00855195006180	K152267	000