FDA UDI
In Commercial Distribution
🇺🇸 United States
Calvary Spine Pedicle Screw System
DI: B1145600
·
Model: 560
·
CALVARY SPINE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Calvary Spine Pedicle Screw System
- Primary DI
- B1145600
- Version / Model
- 560
- Catalog Number
- 560
- Company Name
- CALVARY SPINE, LLC
- Labeler DUNS
- 832116532
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-24
- Public Version
- 2
- Public Version Date
- 2024-05-27
- Public Version Status
- Update
- Public Device Record Key
- 815fd41c-a502-4f3f-aad4-c5a0ea030ce1
Device Description
PreLordosed Rod 5.5mm Diameter 60mm length Ti6Al4V
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
- Yes
- 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 |
|---|---|---|---|---|
| 65116 | Bone-screw internal spinal fixation system rod | An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1145600 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201568 | 000 |