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InSePtion MIS Fixation System

FDA UDI

Class I (US FDA UDI)

by Kalitec Direct LLC

Identity

Trade Name
InSePtion MIS Fixation System FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Sizer, Smooth, Ratcheting FDA UDI
Model / Reference
14-K01-1010 FDA UDI
Description
Sizer, Smooth, Ratcheting FDA UDI

Identifiers

Primary DI / UDI-DI
B07314K0110100 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

InSePtion MIS Fixation System 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 216c519a-eb83-44c1-9116-2dd2c36fc583 33 fields · synced May 31, 2026