Identity
- Trade Name
- NaviNetics Skull Anchor Rescue Screw Kit FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Model / Reference
- NN1400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850023620009 FDA UDI
- 510(k) Number
- K210700 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Neurological stereotactic surgery system
NaviNetics Skull Anchor Rescue Screw Kit by Navinetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurological stereotactic surgery system.
- Gauge for Softouch Registration Pointer — Brainlab SE · Class I
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- Mini-Bolt VUE Accessory Kit — MONTERIS MEDICAL CORP · Class I
- StealthAiR™ Spine — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
- PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
Cleared under the same submission
K210700 also covers:
- NaviNetics CT Localizer Kit — NAVINETICS INC.
- NaviNetics Cannula and Stylet Kit — NAVINETICS INC.
- NaviNetics Ground Truth Fixture — NAVINETICS INC.
- NaviNetics Key Placement Guide Kit — NAVINETICS INC.
- NaviNetics MR Localizer Kit — NAVINETICS INC.
- NaviNetics MR Localizer Tubing Kit — NAVINETICS INC.
- NaviNetics Reusable Stereotactic Frame — NAVINETICS INC.
- NaviNetics Reusable Stereotactic System — NAVINETICS INC.
- NaviNetics Skull Anchor Key Kit — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Navinetics Inc.
Sources (1)
- FDA UDI c841e87f-50b1-4feb-97d6-ecd85d2db621 33 fields · synced May 30, 2026