AccessGUDID - DEVICE: M2A - MODULAR HEAD HIP SYSTEM (00880304647275)

GUDID

Device Identifier (DI) Information

Brand Name: M2A - MODULAR HEAD HIP SYSTEM
Version or Model: BH400340
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BH400340
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304647275
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?
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061423	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: 40MM HEAD SIZE Ø TYPE 12/14 TAPER

Device Record Status

Public Device Record Key: 43f1f79b-1fad-463d-87b5-cb2e69413f7b
Public Version Date: May 30, 2025
Public Version Number: 3
DI Record Publish Date: March 25, 2020