FDA UDI
In Commercial Distribution
🇺🇸 United States
Black Diamond Pedicle Screw System
DI: B062100100000J
·
Model: 1001-0000
·
Osseus Fusion Systems, LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Black Diamond Pedicle Screw System
- Primary DI
- B062100100000J
- Version / Model
- 1001-0000
- Catalog Number
- 1001-0000 to 1010-9999
- Company Name
- Osseus Fusion Systems, LLC
- Labeler DUNS
- 933442068
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e756f3cc-63df-4aba-b7b3-e5ed0820bc3b
Device Description
The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
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
- 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 |
|---|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | 888.3070 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61325 | Bone-screw internal spinal fixation system, non-sterile | An assembly of non-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. Non-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 |
|---|---|---|---|---|---|---|
| Direct Marking | 71341402JV | HIBCC | ||||
| Primary | B062100100000J | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 300 | Millimeter | |
| Length | 250 | Millimeter | |
| Length | 200 | Millimeter | |
| Length | 120 | Millimeter | |
| Length | 115 | Millimeter | |
| Length | 110 | Millimeter | |
| Length | 105 | Millimeter | |
| Length | 40 | Millimeter | |
| Length | 35 | Millimeter | |
| Length | 30 | Millimeter | |
| Outer Diameter | 8.5 | Millimeter | |
| Outer Diameter | 7.5 | Millimeter | |
| Outer Diameter | 6.5 | Millimeter | |
| Outer Diameter | 5.5 | Millimeter | |
| Outer Diameter | 4.5 | Millimeter | |
| Depth | 90 | Millimeter | |
| Depth | 70 | Millimeter | |
| Depth | 50 | Millimeter | |
| Depth | 35 | Millimeter | |
| Depth | 30 | Millimeter | |
| Length | 45 | Millimeter | |
| Length | 50 | Millimeter | |
| Length | 55 | Millimeter | |
| Length | 60 | Millimeter | |
| Length | 65 | Millimeter | |
| Length | 70 | Millimeter | |
| Length | 75 | Millimeter | |
| Length | 80 | Millimeter | |
| Length | 85 | Millimeter | |
| Length | 90 | Millimeter | |
| Length | 95 | Millimeter | |
| Length | 100 | Millimeter |