DEVICE: Black Diamond Pedicle Screw System (B062100100000J)
Device Identifier (DI) Information
Black Diamond Pedicle Screw System
1001-0000
In Commercial Distribution
1001-0000 to 1010-9999
Osseus Fusion Systems, LLC
1001-0000
In Commercial Distribution
1001-0000 to 1010-9999
Osseus Fusion Systems, LLC
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
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
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| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
| MNI | Orthosis, Spinal Pedicle Fixation |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type 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 |
Device Record Status
e756f3cc-63df-4aba-b7b3-e5ed0820bc3b
March 29, 2018
2
February 14, 2017
March 29, 2018
2
February 14, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined