FDA UDI
In Commercial Distribution
🇺🇸 United States
3DP Cervical Interbody System
DI: M719GAC3D12LP0
·
Model: 1
·
Genesys Orthopedics Systems LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3DP Cervical Interbody System
- Primary DI
- M719GAC3D12LP0
- Version / Model
- 1
- Catalog Number
- GAC3D-12LP
- Company Name
- Genesys Orthopedics Systems LLC
- Labeler DUNS
- 017921066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-25
- Public Version
- 1
- Public Version Date
- 2020-07-03
- Public Version Status
- New
- Public Device Record Key
- dd472eb2-10f8-49ec-b6a3-e720265250a6
Device Description
12mm 3DP Stand-Alone Cervical Interbody, Large, Parallel
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 |
|---|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | 888.3080 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38161 | Metallic spinal interbody fusion cage | A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M719GAC3D12LP0 | HIBCC |
Customer Contacts
- Phone
- 5123817070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191489 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 12 | Millimeter |