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Foot Osteotomy Wedge System

FDA UDI

Class II (US FDA UDI)

by Tyber Medical

Identity

Trade Name
Foot Osteotomy Wedge System FDA UDI
Generic Name
Metallic osteotomy fusion cage, non-customized FDA UDI
Model / Reference
08.844.212S FDA UDI

Identifiers

Catalog Number
08.844.212S FDA UDI
Primary DI / UDI-DI
00819917028157 FDA UDI
510(k) Number
K150394 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
PLF 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
888.3040 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

Foot Osteotomy Wedge System by Tyber Medical — 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

K150394 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tyber Medical

Sources (1)

  • FDA UDI 1f8c1931-8ada-4361-8be5-4c5e7c411a6c 34 fields · synced May 29, 2026