AccessGUDID - DEVICE: Pantheon System (08052532830282)

GUDID

Device Identifier (DI) Information

Brand Name: Pantheon System
Version or Model: Salvage Stem (Cemented)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0280511
Company Name: ADLER ORTHO SPA

Primary DI Number: 08052532830282
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338847291 *Terms of Use

Device Description: Pantheon Salvage Cemented Stem L 115 Ø 11

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?
34038	Revision uncoated femoral stem prosthesis	A sterile implantable device designed to replace the proximal femoral neck during replacement of a total hip prosthesis typically due to wear. The device is composed of two or more separate segments designed to be joined (modular), is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included; implantation is intended to be performed with bone cement and may involve use of a femoral extension.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

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
Device Size Text, specify: L115mm, Diameter 11mm

Device Record Status

Public Device Record Key: b4e249d6-5271-4026-a133-4327cd42af26
Public Version Date: March 05, 2025
Public Version Number: 1
DI Record Publish Date: February 25, 2025