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Intelliguides

FDA UDI

Class II (US FDA UDI)

by Mios Marketing, LLC

Identity

Trade Name
Intelliguides FDA UDI
Generic Name
Orthopaedic implant aiming/guiding block, single-use FDA UDI
Device Name
Anterior Closing Wedge Osteotomy Guide, 22mm x 38mm FDA UDI
Model / Reference
Equinox FDA UDI
Description
Anterior Closing Wedge Osteotomy Guide, 22mm x 38mm FDA UDI

Identifiers

Catalog Number
04-1022-038 FDA UDI
Primary DI / UDI-DI
G2710410220380 FDA UDI
510(k) Number
K220717 FDA UDI
FDA Product Code
PBF FDA UDI
GMDN Term
Orthopaedic implant aiming/guiding block, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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

Dimensions & Sizes

Size
Length — 22 Millimeter FDA UDI
Depth — 38 Millimeter FDA UDI

Category: Orthopaedic implant aiming/guiding block, single-use

Intelliguides by Mios Marketing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant aiming/guiding block, single-use.

Cleared under the same submission

K220717 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mios Marketing, LLC

Sources (1)

  • FDA UDI c40f8781-34b8-43b4-a300-0145bf46d7c4 38 fields · synced Jun 8, 2026