FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Integrated Spine System
DI: 00822409024551
·
Model: 158-1055
·
Ortho Development Corporation
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Integrated Spine System
- Primary DI
- 00822409024551
- Version / Model
- 158-1055
- Company Name
- Ortho Development Corporation
- Labeler DUNS
- 876542390
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-31
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- ee7ba627-6c7c-4226-b915-291029bf81f1
- Distribution End Date
- 2016-09-24
Device Description
Diameter 6.0 mm x 55 mm Curved Spinal Rod Ti
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
- Yes
- 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 |
|---|---|---|---|---|
| MNH | Orthosis, spondylolisthesis spinal fixation | Orthopedic | 888.3070 | 2 |
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION | Orthopedic | 888.3070 | 2 |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | Orthopedic | 888.3050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61324 | Bone-screw internal spinal fixation system, sterile | An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822409024551 | GS1 |
Customer Contacts
- Phone
- +1(801)553-9991
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061524 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 6 | Millimeter | |
| Length | 55 | Millimeter |