Home GUDID M209115810 STEM PC SH 12
Primary DI M209115810
Brand STEM PC SH 12
Company BIOPRO, INC.
Model 11581
Published 2015-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M209115810 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Press-fit hip femur prosthesis, modular A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined, and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.
Regulatory Flags# DUNS number 618749857 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M209232580 Hintermann Compressor 23258 2026-05-22 M209232590 Hintermann Distractor 23259 2026-05-22 M209186080 10mm HBS® Standard Compression 18608 2015-09-16 M209186090 11mm HBS® Standard Compression 18609 2015-09-16 M209186100 12mm HBS® Standard Compression 18610 2015-09-16 M209186110 13mm HBS® Standard Compression 18611 2015-09-16 M209186120 14mm HBS® Standard Compression 18612 2015-09-16 M209186130 15mm HBS® Standard Compression 18613 2015-09-16 M209186140 16mm HBS® Standard Compression 18614 2015-09-16 M209186150 17mm HBS® Standard Compression 18615 2015-09-16 M209186160 18mm HBS® Standard Compression 18616 2015-09-16 M209186170 19mm HBS® Standard Compression 18617 2015-09-16 M209186180 20mm HBS® Standard Compression 18618 2015-09-16 M209186190 21mm HBS® Standard Compression 18619 2015-09-16 M209186200 22mm HBS® Standard Compression 18620 2015-09-16 M209186210 23mm HBS® Standard Compression 18621 2015-09-16 M209186220 24mm HBS® Standard Compression 18622 2015-09-16 M209186230 25mm HBS® Standard Compression 18623 2015-09-16 M209186240 26mm HBS® Standard Compression 18624 2015-09-16 M209186250 27mm HBS® Standard Compression 18625 2015-09-16
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07611996118674 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142327 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142334 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142341 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142358 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142365 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142372 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996142389 POLARSTEM Smith & Nephew, Inc. KWY 2017-01-12 07611996074901 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074918 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074925 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074932 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074949 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074956 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074963 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074987 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996074994 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075014 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996075021 SL-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095586 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095593 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095616 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095630 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095647 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095678 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996095685 SLR-PLUS Smith & Nephew, Inc. KWY 2016-08-19 07611996103410 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103427 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103441 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25 07611996103458 POLARSTEM Smith & Nephew, Inc. KWY 2016-07-25