FDA UDI
In Commercial Distribution
🇺🇸 United States
3DP Lumbar Interbody System
DI: M719GLL102M08080
·
Model: 1
·
Genesys Orthopedics Systems LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 3DP Lumbar Interbody System
- Primary DI
- M719GLL102M08080
- Version / Model
- 1
- Catalog Number
- GLL102-M0808
- Company Name
- Genesys Orthopedics Systems LLC
- Labeler DUNS
- 017921066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-12
- Public Version
- 1
- Public Version Date
- 2024-04-22
- Public Version Status
- New
- Public Device Record Key
- 3d8d67d3-0e19-4f32-b55a-07b439c03498
Device Description
LLIF Ingot Trial, Medium 8mm x 8-Degree
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
- 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 |
|---|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 888.3080 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | 888.3060 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61247 | Orthopaedic cement restrictor sizer | A non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the form of a trial prosthesis attached to an inserter, or a rod with a measuring gauge at the distal end. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M719GLL102M08080 | HIBCC |
Customer Contacts
- Phone
- 512-381-7070
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20 | Millimeter | |
| Angle | 6 | degree |