FDA UDI
In Commercial Distribution
🇺🇸 United States
CORUS NAVIGATION ACCESS SYSTEM-GLX
DI: 00852776006690
·
Model: DX-01-180
·
Providence Medical Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CORUS NAVIGATION ACCESS SYSTEM-GLX
- Primary DI
- 00852776006690
- Version / Model
- DX-01-180
- Company Name
- Providence Medical Technology, Inc.
- Labeler DUNS
- 969820245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-03
- Public Version
- 1
- Public Version Date
- 2025-11-11
- Public Version Status
- New
- Public Device Record Key
- b736a33b-e42e-46f4-a3f2-a44eb81b0af1
Device Description
The CORUS™ Navigation Access System-GLX disposable instruments are used during the preparation and usage of CORUS™ Spinal System-LX during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61300 | Internal spinal fixation procedure kit, single-use | A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852776006690 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251060 | 000 |