FDA UDI
In Commercial Distribution
🇺🇸 United States
Response Rib and Pelvic System
DI: 00840194428378
·
Model: 00-1600-4500
·
ORTHOPEDIATRICS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Response Rib and Pelvic System
- Primary DI
- 00840194428378
- Version / Model
- 00-1600-4500
- Catalog Number
- 00-1600-4500
- Company Name
- ORTHOPEDIATRICS CORP.
- Labeler DUNS
- 796416191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-25
- Public Version
- 1
- Public Version Date
- 2024-02-02
- Public Version Status
- New
- Public Device Record Key
- c166e5fe-c1d5-40eb-9439-7fcb0d3908d0
Device Description
PELVIC LOCKING SCREW, 50.0
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 Conditional
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDI | Prosthesis, rib replacement | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47493 | Vertical expandable prosthetic rib system | An assembly of implantable devices designed to treat a patient with complex chest wall and/or spinal deformities, typically thoracic insufficiency syndrome (TIS) in paediatric patients (a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development). The assembly typically consists of telescoping rods/bars, fixation hooks, and locking screws/clamps made of surgical stainless steel or titanium (Ti), and are typically vertically attached to the ribs, spine, and/or pelvis to help straighten the spine and separate ribs so that the lungs can grow and fill with sufficient air for breathing. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840194428378 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233105 | 000 |