FDA UDI
In Commercial Distribution
🇺🇸 United States
Fitmore® Hip Stem
DI: 00889024281165
·
Model: 01.00551.202
·
Zimmer GmbH
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fitmore® Hip Stem
- Primary DI
- 00889024281165
- Version / Model
- 01.00551.202
- Company Name
- Zimmer GmbH
- Labeler DUNS
- 488133448
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-07
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4ddb1738-557b-4c68-8db5-5a3cea090abd
Device Description
Fitmore Hip Stem B, Size 2
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| KWA | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | Orthopedic | 888.3330 | 3 |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | Orthopedic | 888.3350 | 2 |
| JDL | Prosthesis, hip, semi-constrained (metal cemented acetabular component) | Orthopedic | 888.3320 | 3 |
| KWL | Prosthesis, hip, hemi-, femoral, metal | Orthopedic | 888.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33581 | Coated hip femur prosthesis, modular | A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024281165 | GS1 |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 |