FDA UDI
In Commercial Distribution
🇺🇸 United States
OP Response Spine System
DI: 00840194445511
·
Model: 00-1301-5675
·
ORTHOPEDIATRICS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OP Response Spine System
- Primary DI
- 00840194445511
- Version / Model
- 00-1301-5675
- Catalog Number
- 00-1301-5675
- Company Name
- ORTHOPEDIATRICS CORP.
- Labeler DUNS
- 796416191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-30
- Public Version
- 3
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 252697bc-8ecf-4f92-a421-d76235a06e7c
Device Description
5.5/6.0 Closed Polyaxial Pedicle Screw, 6.5mm x 75mm
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 |
|---|---|---|---|---|
| NKB | Thoracolumbosacral pedicle screw system | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46651 | Spinal bone screw, non-bioabsorbable | A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840194445511 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150600 | 000 |