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Savant Lumbar Interbody Fusion System

FDA UDI

Class II (US FDA UDI)

by Curiteva, LLC

Identity

Trade Name
Savant Lumbar Interbody Fusion System FDA UDI
Generic Name
Orthopaedic fixation plate file/rasp FDA UDI
Device Name
8mm Angled Right Rasp, Bayoneted FDA UDI
Model / Reference
C445-110 FDA UDI
Description
8mm Angled Right Rasp, Bayoneted FDA UDI

Identifiers

Primary DI / UDI-DI
B648C4451100 FDA UDI
510(k) Number
K181589 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Orthopaedic fixation plate file/rasp FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 8 Millimeter FDA UDI

Category: Orthopaedic fixation plate file/rasp

Savant Lumbar Interbody Fusion System by Curiteva, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic fixation plate file/rasp.

Cleared under the same submission

K181589 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Curiteva, LLC

Sources (1)

  • FDA UDI d615123c-305d-4f59-9a2e-f84095506f04 36 fields · synced Jun 8, 2026