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510(k) K202338

Device
SpaceFlex Shoulder
Applicant
G21 Srl
510(k) number
K202338
Product code
MBB  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-17
Date received
2020-08-17
Regulation
888.3027
Classification name
Bone Cement, Antibiotic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Filippo Foroni
Address
Via Sandro Pertini, 8 San Possidonio IT 41039 41039

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252443SpaceFix Shoulder SpacerG21, S.R.L.2025-09-15
K242216GENTAFIX® (1, 3, 3MV)Teknimed Sas2024-12-18
K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH2024-11-20
K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.2022-12-28
K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.2022-09-15
K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.2022-09-02
K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.2020-08-13
K192041G21 SpaceFlex HipG21, S.R.L.2019-10-29
K190216SpaceFlex KneeG21, S.R.L.2019-06-09
K161273StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisBiomet, Inc.2017-01-25
K161166StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, Inc.2016-09-08
K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.2016-06-16
K150850Refobacin Bone Cement RBiomet, Inc.2015-07-16
K131135BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESISBiomet Manufacturing Corp2014-01-22
K081163SMARTSET GMV GENTAMICIN BONE CEMENTDePuy Orthopaedics, Inc.2008-05-14

Legacy Summary#

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FDA Review#

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