FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnifit
DI: 07613327023497
·
Model: 6070-0525A
·
Howmedica Osteonics Corp.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Omnifit
- Primary DI
- 07613327023497
- Version / Model
- 6070-0525A
- Catalog Number
- 6070-0525A
- Company Name
- Howmedica Osteonics Corp.
- Labeler DUNS
- 058311945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f687ee81-374d-4dc7-b3be-74b98c78731e
Device Description
Hip Stem
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented | Orthopedic | 888.3360 | 2 |
| KWL | Prosthesis, hip, hemi-, femoral, metal | Orthopedic | 888.3360 | 2 |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | Orthopedic | 888.3350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38155 | Press-fit femoral stem prosthesis | A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327023497 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031744 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Taper Connection: C-TPR | ||
| Device Size Text, specify | Size: 5 | ||
| Device Size Text, specify | Neck Angle: 132.0 Degree | ||
| Device Size Text, specify | Neck Length: 25.0 Millimeter |