AccessGUDID - DEVICE: OSS™ Orthopedic Salvage System (00880304674554)

GUDID

Device Identifier (DI) Information

Brand Name: OSS™ Orthopedic Salvage System
Version or Model: 151857
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 151857
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304674554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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?
48066	Knee femur stem prosthesis	A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.	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
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002757	000
K021260	000
K051479	000
K051570	000
K060131	000
K080330	000
K123501	000
K140509	000
K141331	000

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: 11 MM 120 MM

Device Record Status

Public Device Record Key: 33c47401-8ed2-4725-9e0a-cea8c8a52f4b
Public Version Date: May 30, 2025
Public Version Number: 7
DI Record Publish Date: October 24, 2015