AccessGUDID - DEVICE: M2a Magnum™ Hip System (00880304993532)

GUDID

Device Identifier (DI) Information

Brand Name: M2a Magnum™ Hip System
Version or Model: US157858
Commercial Distribution Status: In Commercial Distribution
Catalog Number: US157858
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304993532
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?	MR Unsafe
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
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042037	000
K101336	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: 58MM OUTER Ø 52MM INNER Ø

Device Record Status

Public Device Record Key: f34a7aab-9f4d-4200-b907-11fff166eb0e
Public Version Date: May 30, 2025
Public Version Number: 6
DI Record Publish Date: October 06, 2017