Identity
- Trade Name
- WayPoint™ Anchors FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- microTargeting WayPoint Anchors, 4mm, nonsterile FDA UDI
- Model / Reference
- 66-WP-AN-00313 FDA UDI
- Description
- microTargeting WayPoint Anchors, 4mm, nonsterile FDA UDI
Identifiers
- Catalog Number
- 66-WP-AN FDA UDI
- Primary DI / UDI-DI
- 00873263003138 FDA UDI
- 510(k) Number
- K092192 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 4 Millimeter FDA UDI
Category: Neurological stereotactic surgery system
WayPoint™ Anchors by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurological stereotactic surgery system.
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- Leksell Stereotactic System — Elekta Instrument AB · Class II
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Cleared under the same submission
K092192 also covers:
- MicroTargeting™ RPD Adapter — FHC, INC.
- MicroTargeting™ Sterilization Basket — FHC, INC.
- OsteoMed™ Manual Driver Handle — FHC, INC.
- STar™ Drive Lead Measurement Fixture — FHC, INC.
- WayPoint™ Anchors — FHC, INC.
- WayPoint™ Combination Driver Bit — FHC, INC.
- WayPoint™ Hex Wrench — FHC, INC.
- WayPoint™ Implantation Kit — FHC, INC.
- WayPoint™ Multi-Oblique Platform — FHC, INC.
- WayPoint™ Navigator — FHC, INC.
- WayPoint™ Navigator — FHC, INC.
- WayPoint™ Navigator — FHC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI 2e703934-a162-4e3e-8f01-2441711340bf 37 fields · synced May 30, 2026