DEPUY TRI-LOCK BONE PRESERVATION STEM

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Tri-lock Bone Preservation Stem.

Pre-market Notification Details

Device IDK073570
510k NumberK073570
Device Name:DEPUY TRI-LOCK BONE PRESERVATION STEM
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactRhonda Myer
CorrespondentRhonda Myer
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeKWA  
Subsequent Product CodeLPH
Subsequent Product CodeLZO
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-20
Decision Date2008-02-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295033844 K073570 000
10603295033486 K073570 000
10603295033479 K073570 000
10603295033462 K073570 000
10603295033332 K073570 000
10603295033325 K073570 000
10603295033318 K073570 000
10603295033301 K073570 000
10603295000792 K073570 000
10603295033653 K073570 000
10603295033660 K073570 000
10603295033677 K073570 000
10603295033837 K073570 000
10603295033820 K073570 000
10603295033813 K073570 000
10603295033721 K073570 000
10603295033714 K073570 000
10603295033707 K073570 000
10603295033691 K073570 000
10603295033684 K073570 000
10603295000716 K073570 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.