FDA UDI
In Commercial Distribution
🇺🇸 United States
RESPONSE 5.5/6.0 SPINE SYSTEM
DI: 00841132183441
·
Model: 00-1350-9520
·
ORTHOPEDIATRICS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RESPONSE 5.5/6.0 SPINE SYSTEM
- Primary DI
- 00841132183441
- Version / Model
- 00-1350-9520
- Catalog Number
- 00-1350-9520
- Company Name
- ORTHOPEDIATRICS CORP.
- Labeler DUNS
- 796416191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-05
- Public Version
- 1
- Public Version Date
- 2020-03-13
- Public Version Status
- New
- Public Device Record Key
- 83404c34-ff61-4848-9fec-32ccd0ff7691
Device Description
5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 20mm Length
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
- Yes
- 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 |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | Orthopedic | 888.3050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37272 | Trans-facet-screw internal spinal fixation system, sterile | A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841132183441 | GS1 |
Customer Contacts
- Phone
- +1(574)268-6379
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181390 | 000 |