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Navagio

FDA UDI

Class I (US FDA UDI)

by Kalitec Direct LLC

Identity

Trade Name
Navagio FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Trial, TLIF, 32L OB CRV 7Deg, 16mm FDA UDI
Model / Reference
30-K01-4216 FDA UDI
Description
Trial, TLIF, 32L OB CRV 7Deg, 16mm FDA UDI

Identifiers

Catalog Number
30-K01-4216 FDA UDI
Primary DI / UDI-DI
B07330K0142160 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Navagio by Kalitec Direct LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kalitec Direct LLC

Sources (1)

  • FDA UDI 379583e2-e55e-49c1-a64a-7a25f1f70f86 34 fields · synced Jun 1, 2026