FDA Registration
Active
🇺🇸 United States
GPS System
Reg #: 3027595873
·
FEI: 3027595873
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WAYPOINT ORTHOPEDICS
- Registration Number
- 3027595873
- FEI Number
- 3027595873
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7 Great Valley Pkwy Ste 295
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222106
Owner / Operator
- Firm Name
- Waypoint Orthopedics
- Operator Number
- 10088311
- Address
- 7 Great Valley Parkway, Suite 295
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
- Correspondent
- Tiffini Wittwer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Optical Neurosurgical Nerve Locator | QWP | Class 2 | Ear, Nose, Throat | No | 2023-06-27 |
Proprietary Names
GPS System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility