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510(k) K220142

Device
BRM Digitalis Spacer
Applicant
Brm Extremities Srl
510(k) number
K220142
Product code
KYJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-04
Date received
2022-01-18
Regulation
888.3230
Classification name
Prosthesis, Finger, Constrained, Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Andrea De Maglio
Address
Via Papa Giovanni Xxiii, 9 Civate IT 23862 23862

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KYJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.2023-12-14
K211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA2022-07-27
K140453OSTEOTEC SILICONE FINGER IMPLANTOsteotec, Ltd.2015-04-17
K083107MODIFICATION TO DEPUY NEUFLEX PIP FINGERDePuy Orthopaedics, Inc.2009-02-09
K082231ASCENSION SILICONE PIPAscension Orthopedics, Inc.2009-01-12
K022892ASCENSION SILLICONE MCPAscension Orthopedics, Inc.2002-11-25
K013629FINGER JOINT PROSTHESISAvanta Orthopaedics, Inc.2002-01-25
K001922DEPUY NEUFLEX PIP FINGERDepuy, Inc.2000-08-29
K970544DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESISDepuy, Inc.1997-09-12
K931588SUTTER PROXIMAL INTERPHALANGEAL JOINTSutter Corp.1994-03-10
K870200SUTTER FINGER JOINT PROSTHESISSutter Biomedical, Inc.1987-10-09
K781380MARNE M.T.P.J. ORTHOPEDIC IMPLANTFarah , Ltd.1979-02-21
K781668GAMMA RADIATION STERILIZATION PRECEDURECutter Laboratories, Inc.1978-11-03