FDA UDI
In Commercial Distribution
🇺🇸 United States
Black Diamond Pedicle Screw System
DI: B06210101017
·
Model: 1010-1017
·
Osseus Fusion Systems, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Black Diamond Pedicle Screw System
- Primary DI
- B06210101017
- Version / Model
- 1010-1017
- Catalog Number
- 1010-1017
- Company Name
- Osseus Fusion Systems, LLC
- Labeler DUNS
- 933442068
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-12
- Public Version
- 3
- Public Version Date
- 2024-08-27
- Public Version Status
- Update
- Public Device Record Key
- d8efa368-447b-4b7a-8860-f39c02cdc72d
Device Description
ROD BENDER, BLK DIAMOND
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 |
|---|---|---|---|---|
| 60741 | Spinal rod bending system | An assembly of mains electricity (AC-powered) computerized devices intended to be used to determine the relative locations of internal spinal fixation system implants (e.g., screws, hooks) for the production of bend instructions to shape a spinal rod during spinal fusion surgery. It primarily consists of an electronic spatial measurement system used with manual tools to determine implant location and to take measurements; computer/software to convert implant locations to a series of bend instructions; and an orthopaedic rod bender to execute bend instructions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B06210101017 | HIBCC |
Customer Contacts
- Phone
- 888-330-5960
- [email protected]