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Wedge System Instruments

FDA UDI

Class I (US FDA UDI)

by Tyber Medical

Identity

Trade Name
Wedge System Instruments FDA UDI
Generic Name
Polymeric osteotomy fusion cage, non-customized FDA UDI
Device Name
Evans 18 x 12 Trial FDA UDI
Model / Reference
006-E18125 FDA UDI
Description
Evans 18 x 12 Trial FDA UDI

Identifiers

Catalog Number
006-E18125 FDA UDI
Primary DI / UDI-DI
M695006E181250 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Polymeric osteotomy fusion cage, non-customized 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

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
MRI Safety
MR Conditional FDA UDI

Category: Polymeric osteotomy fusion cage, non-customized

Wedge System Instruments by Tyber Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tyber Medical

Sources (1)

  • FDA UDI 76418d5b-d9d4-4dae-9e59-c789edc2f2dd 35 fields · synced May 30, 2026