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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K233476
Device Name Z1 Hip System
Applicant
Orchard Medical Development
9450 W. Bryn Mawr Ave.
Suite 200
Rosemont,  IL  60018
Applicant Contact Brett Zarda
Correspondent
Secure Biomed Evalutations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Gracyalny Justin
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   KWZ   LWJ   MEH  
Date Received10/25/2023
Decision Date 02/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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