FDA.reportPublic FDA data

510(k) K212431

Device
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
Applicant
Biomet, Inc.
510(k) number
K212431
Product code
JDG
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-07
Date received
2021-08-04
Regulation
888.3360
Classification name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gregory Foster
Address
56 E. Bell Dr., P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193546Distal CentralizersBiomet, Inc.2020-09-25
K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics2018-03-19
K001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTStelkast Company2000-09-27
K992234THE TAPER-FIT TOTAL HIP SYSTEMCorin USA1999-11-10
K962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMExactech, Inc.1996-08-08
K955171NEXLOCK FEMORAL STEMNexmed, Inc.1996-02-09
K953653LUBINUS SP II HIP SYSTEMTurnkey Intergration USA, Inc.1995-11-06
K953067HIP FRACTURE STEM FENESTRATION PLUGHowmedica Corp.1995-08-21
K945783ORTHOMET TITANIUM HYBRID FEMORAL STEMOrthomet, Inc.1995-05-30
K951083PROFORM CEMENTED FEMORAL COMPONENTStelkast Company1995-05-22
K942479INTEGRAL CO-CR FEMORAL COMPONENTBiomet, Inc.1994-09-20
K942028RX90 FEMORAL COMPONENTBiomet, Inc.1994-09-19
K942027IMPACT CO-CR 1-PIECE FEMORAL COMPONENTBiomet, Inc.1994-09-19
K931194CO-CR ANSWER FEMORAL COMPONENTBiomet, Inc.1994-05-05
K935078S-ROM TOTAL HIP REPLACEMENT SYSTEMJoint Medical Products Corp.1994-03-09