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510(k) K201157

Device
Prime BIOFOAM® Multi-Hole Shells
Applicant
Microport Orthopedics, Inc.
510(k) number
K201157
Product code
MBL
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-24
Date received
2020-04-30
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Vaidehi Mehta
Address
5677 Airline Rd. Arlington TN US 38002 38002

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.2020-10-06
K182535R3 Anteverted LinersSmith & Nephew, Inc.2018-11-19
K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.2016-12-14
K122382DYNASTY BIOFOAM SHELLWrightmedicaltechnologyinc2012-10-22
K113848R3 XLPE LINERSSmith & Nephew, Inc.2012-04-27
K102370R3 XLPE ANTEVERTED LINERSSmith & Nephew, Inc.2011-01-19
K093363COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERSSmith & Nephew, Inc.2010-01-26
K092386R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERSSmith & Nephew, Inc.2009-11-03
K070756SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEMSmith & Nephew, Inc.2007-06-06
K061253REFLECTION 3 ACETABULAR SYSTEMSmith & Nephew, Inc.2006-05-31
K960094REFLECTION DUAL DIMENSION SHELLSmith & Nephew Richards, Inc.1996-03-27
K931107LOGYK ACETABULAR COMPONENT SYSTEMArthronics, Inc.1994-03-28