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INTREPED, Intraosseous Fusion Device

FDA UDI

Class II (US FDA UDI)

by Auxano Medical LLC

Identity

Trade Name
INTREPED, Intraosseous Fusion Device FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
INTREPED 10x10 implant FDA UDI
Model / Reference
01-11010 FDA UDI
Description
INTREPED 10x10 implant FDA UDI

Identifiers

Catalog Number
01-11010 FDA UDI
Primary DI / UDI-DI
00850055649552 FDA UDI
510(k) Number
K231649 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthopaedic bone screw (non-sliding)

INTREPED, Intraosseous Fusion Device by Auxano Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Cleared under the same submission

K231649 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Auxano Medical LLC

Sources (1)

  • FDA UDI 9d2b86f0-f1b6-4c78-80bd-42391e4e7f5d 36 fields · synced Jun 8, 2026