FDA UDI
In Commercial Distribution
🇺🇸 United States
Iconacy i-Hip
DI: M914011020201201
·
Model: 01-10202-012-01
·
Iconacy Orthopedic Implants LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Iconacy i-Hip
- Primary DI
- M914011020201201
- Version / Model
- 01-10202-012-01
- Catalog Number
- 01-10202-012-01
- Company Name
- Iconacy Orthopedic Implants LLC
- Labeler DUNS
- 032218374
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-06
- Public Version
- 4
- Public Version Date
- 2020-04-06
- Public Version Status
- Update
- Public Device Record Key
- d81b5316-4155-45ac-a183-c626ef4712ad
Device Description
FEMORAL HEAD, 32MM DIAMETER, +12MM NECK
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
- Yes
- 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 |
|---|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33175 | Metallic femoral head prosthesis | An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M914011020201201 | HIBCC |
Customer Contacts
- Phone
- 574-269-4266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121034 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 32 | Millimeter |