WAYPOINT ORTHOPEDICS

FDA Device Registration & Listing · Malvern, PA, US · Registration 3027595873

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027595873
FEI Number
3027595873
Entity Name
WAYPOINT ORTHOPEDICS
City/State/Country
Malvern, PA, US
Establishment Address
7 Great Valley Pkwy Ste 295, Malvern, PA 19355, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Waypoint Orthopedics (Owner Number: 10088311)
Owner / Operator Contact Address
7 Great Valley Parkway, Suite 295, Malvern, PA 19355, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222106
PMA Number
N/A

All Registered Proprietary Names

Guided Pedicle System (GPS)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QWP Optical Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2023-06-27

Official Correspondent

Tiffini Wittwer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Waypoint Orthopedics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027595873. Last updated year: 2026. Please use registration number 3027595873 when referencing this establishment in official correspondence.
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