Nouvatec, LLC

FDA Device Registration & Listing · Walnut Spgs, TX, US · Registration 3012607373

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
3012607373
FEI Number
3012607373
Entity Name
Nouvatec, LLC
City/State/Country
Walnut Spgs, TX, US
Establishment Address
5986 Highway 144, Walnut Spgs, TX 76690, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Nouvatec LLC (Owner Number: 10052407)
Owner / Operator Contact Address
5986 Highway 144, Walnut Springs, TX 76690, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K042434
PMA Number
N/A

All Registered Proprietary Names

Nouvag AG

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2025-02-11
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-02-11
DZI Drill, Bone, Powered Dental Class 2 872.4120 2025-02-11
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2025-02-11

Official Correspondent

Mark Kuban

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012607373. Last updated year: 2026. Please use registration number 3012607373 when referencing this establishment in official correspondence.
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