AccessGUDID - DEVICE: OSS™ Orthopedic Salvage System (00887868267192)

GUDID

Device Identifier (DI) Information

Brand Name: OSS™ Orthopedic Salvage System
Version or Model: 151865
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 151865
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868267192
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?
61559	Femur/tibia shaft prosthesis	A sterile implantable device designed to replace the shaft (body) of the femur/tibia following resection of the femur/tibia (e.g., due to tumour). It typically connects proximally to a femoral stem prosthesis or knee tibia prosthesis and distally to a sleeve femoral/tibial extension, knee femur prosthesis, or body femoral/tibial extension stem; it is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

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
K152621	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: Ø14 mm 24 cm Arcos®/OSS Tapers With Screws

Device Record Status

Public Device Record Key: 2a8fecbf-29c6-4b50-8c98-37cac15dff75
Public Version Date: May 30, 2025
Public Version Number: 4
DI Record Publish Date: November 13, 2018