Home GUDID 10603295170648 S-ROM ZTT
Primary DI 10603295170648
Brand S-ROM ZTT
Company DEPUY ORTHOPAEDICS, INC.
Model 52-1485
Catalog number 521485
Device description S-ROM Modular Hip System ZTT Proximal Sleeve POROUS COATED 18 B LRG FITS: 18 x 13 STEM Cone: B Triangle: Lrg
Published 2015-03-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MRA Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10603295170648 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10603295170648 10603295170648
GMDN Terms# Term, Definition table Term Definition Sleeve femoral/tibial extension, coated A sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included.
Regulatory Flags# DUNS number 080506581 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 03596010194466 SYNERGY Smith & Nephew, Inc. MRA 2015-05-06 03596010194435 SYNERGY Smith & Nephew, Inc. MRA 2015-05-05 03596010194480 SYNERGY Smith & Nephew, Inc. MRA 2015-05-05 03596010194442 SYNERGY Smith & Nephew, Inc. MRA 2015-05-04 03596010194459 SYNERGY Smith & Nephew, Inc. MRA 2015-05-04 03596010194497 SYNERGY Smith & Nephew, Inc. MRA 2015-05-04 03596010194510 SYNERGY Smith & Nephew, Inc. MRA 2015-05-04 03596010194473 SYNERGY Smith & Nephew, Inc. MRA 2015-05-01 03596010194503 SYNERGY Smith & Nephew, Inc. MRA 2015-05-01 03596010194527 SYNERGY Smith & Nephew, Inc. MRA 2015-05-01 10603295000723 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000730 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000747 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000754 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000761 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000778 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000785 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000808 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000815 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000822 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295000839 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001027 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001034 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001041 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001058 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001065 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001072 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001089 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001096 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24 10603295001102 TRI-LOCK GRIPTION DEPUY ORTHOPAEDICS, INC. MRA 2015-03-24
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