FDA UDI
In Commercial Distribution
🇺🇸 United States
3DP Cervical Interbody System
DI: M719GC3THSS100
·
Model: 1
·
Genesys Orthopedics Systems LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 3DP Cervical Interbody System
- Primary DI
- M719GC3THSS100
- Version / Model
- 1
- Catalog Number
- GC3-THS-S10
- Company Name
- Genesys Orthopedics Systems LLC
- Labeler DUNS
- 017921066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-29
- Public Version
- 1
- Public Version Date
- 2020-10-07
- Public Version Status
- New
- Public Device Record Key
- 7aa10a6a-b235-4878-8ded-23b88fd34836
Device Description
Small 10mm 3DP Cervical Trial with Handle
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
- 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 |
|---|---|---|---|---|
| 44788 | Spinal implant trial | A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M719GC3THSS100 | HIBCC |
Customer Contacts
- Phone
- 5123817070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191489 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 10 | Millimeter |