FDA UDI
In Commercial Distribution
🇺🇸 United States
3DP Lumbar Interbody System
DI: M719GLL102L1008SST0
·
Model: 1
·
Genesys Orthopedics Systems LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3DP Lumbar Interbody System
- Primary DI
- M719GLL102L1008SST0
- Version / Model
- 1
- Catalog Number
- GLL102-L1008S-ST
- Company Name
- Genesys Orthopedics Systems LLC
- Labeler DUNS
- 017921066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-14
- Public Version
- 1
- Public Version Date
- 2025-01-22
- Public Version Status
- New
- Public Device Record Key
- 5aead006-6022-42b2-893b-11b1dc643e30
Device Description
LLIF Stick Trial, Large 10mm x 8°, Straight
Device Characteristics
- Single Use
- No
- 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 | M719GLL102L1008SST0 | HIBCC |
Customer Contacts
- Phone
- 512-381-7070
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Millimeter | |
| Angle | 8 | degree |