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Additive Orthopaedic Bone Wedge System

FDA UDI

Class II (US FDA UDI)

by Additive Orthopaedics Llc

Identity

Trade Name
Additive Orthopaedic Bone Wedge System FDA UDI
Generic Name
Metallic osteotomy fusion cage, non-customized FDA UDI
Device Name
Evans Bone Segment - 18x18x10 FDA UDI
Model / Reference
AOEW-18-10 FDA UDI
Description
Evans Bone Segment - 18x18x10 FDA UDI

Identifiers

Primary DI / UDI-DI
00850005508014 FDA UDI
510(k) Number
K153207 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Metallic osteotomy fusion cage, non-customized 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Metallic osteotomy fusion cage, non-customized

Additive Orthopaedic Bone Wedge System by Additive Orthopaedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic osteotomy fusion cage, non-customized.

Cleared under the same submission

K153207 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Additive Orthopaedics Llc

Sources (1)

  • FDA UDI c4f02531-2316-44c3-a5d5-b0528a853d21 35 fields · synced Jun 8, 2026