FDA UDI
In Commercial Distribution
🇺🇸 United States
M2a Magnum™ Hip System
DI: 00880304993525
·
Model: US157856
·
Biomet Orthopedics, LLC
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- M2a Magnum™ Hip System
- Primary DI
- 00880304993525
- Version / Model
- US157856
- Catalog Number
- US157856
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-06
- Public Version
- 5
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- d790971d-8cc2-4f1c-bb34-f3f172a6c322
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | Orthopedic | 888.3353 | 2 |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented | Orthopedic | 888.3390 | 2 |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
| OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented | Orthopedic | 888.3358 | 2 |
| KWA | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | Orthopedic | 888.3330 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00880304993525 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 56MM OUTER Ø 50MM INNER Ø |