FDA UDI
In Commercial Distribution
🇺🇸 United States
Guided Pedicle System (GPS)
DI: 00196852379552
·
Model: W101
·
Waypoint Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Guided Pedicle System (GPS)
- Primary DI
- 00196852379552
- Version / Model
- W101
- Company Name
- Waypoint Orthopedics, Inc.
- Labeler DUNS
- 144837124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-16
- Public Version
- 1
- Public Version Date
- 2026-01-26
- Public Version Status
- New
- Public Device Record Key
- bb5b4ea2-9994-4fbc-be10-e49f76acde8b
Device Description
Single use, disposable device and a software application that is downloaded onto the provided tablet. The system is intended to provide feedback to surgeons during pilot hole drilling for pedicle screw placement.
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QWP | Optical Neurosurgical Nerve Locator | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65866 | Pedicle screw guide | A thin metal rod intended to guide the implantation of a pedicle screw during a minimally-invasive procedure, where it can also function as a guide for a gauge to provide a screw length measurement. It is inserted into the pedicle of a vertebra so that a cannulated pedicle screw is advanced over the guide, after a gauge is used over the guide to provide a measurement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00196852379552 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222106 | 000 |