AccessGUDID - DEVICE: S-ROM ZTT (10603295175346)

GUDID

Device Identifier (DI) Information

Brand Name: S-ROM ZTT
Version or Model: 55-0534
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 550534
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295175346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: S-ROM Modular Hip System ZTT Proximal Sleeve POROUS COATED 20 D LRG FITS: 20 x 15 STEM Cone: D Triangle: LRG

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61556	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRA	Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f5f5e285-e3f8-431c-8e01-097c38e43eb6
Public Version Date: February 10, 2025
Public Version Number: 6
DI Record Publish Date: March 24, 2015