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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K223441
Device Name SpaceFlex Acetabular Cup
Applicant
G21, S.R.L.
Via Sandro Petrini, 8
San Possidonio,  IT 41039
Applicant Contact Filippo Foroni
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Amesbury,  MA  01913
Correspondent Contact Barry E Sands
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Code
KWL  
Date Received11/14/2022
Decision Date 03/23/2023
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
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