FDA UDI
In Commercial Distribution
🇺🇸 United States
InSitu Hip System
DI: 00816127024061
·
Model: 10-10-0000
·
NEXTSTEP ARTHROPEDIX, LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InSitu Hip System
- Primary DI
- 00816127024061
- Version / Model
- 10-10-0000
- Catalog Number
- 10-10-0000
- Company Name
- NEXTSTEP ARTHROPEDIX, LLC
- Labeler DUNS
- 060211165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6c033796-d36d-45c1-bf5c-9ea71a5dcab8
Device Description
Femoral Stem, Size 0, Standard
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
- Yes
- 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 |
|---|---|---|---|---|
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | 888.3353 | 2 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | 888.3358 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55833 | Press-fit 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 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 may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816127024061 | GS1 |
Customer Contacts
- Phone
- 3307337600
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 112 | Millimeter |