Identity
- Trade Name
- NaviNetics Microdrive Adapter A FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Model / Reference
- NN0160 FDA UDI
Identifiers
- Catalog Number
- NN0160 FDA UDI
- Primary DI / UDI-DI
- 10850023620184 FDA UDI
- 510(k) Number
- K231392 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Neurological stereotactic surgery system
NaviNetics Microdrive Adapter A by Navinetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231392 also covers:
- NaviNetics Cannula and Stylet Kit (To Target) — NAVINETICS INC.
- NaviNetics Driver Handle — NAVINETICS INC.
- NaviNetics Microdrive Adapter F — NAVINETICS INC.
- NaviNetics Skull Anchor Extended Rescue Screw Kit — NAVINETICS INC.
- NaviNetics Skull Anchor Extended Screw Kit — NAVINETICS INC.
- NaviNetics Skull Anchor Key and Drill — NAVINETICS INC.
- NaviNetics Standard Skull Anchor Screw — NAVINETICS 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
- Navinetics Inc.
Sources (1)
- FDA UDI 39c2b103-70a1-4745-8c7a-6a9bd513c1b9 34 fields · synced Jun 1, 2026