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Valeo

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name
VALEO FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Osteotome Straight, 12 FDA UDI
Model / Reference
91.001.1012 FDA UDI
Description
Osteotome Straight, 12 FDA UDI

Identifiers

Primary DI / UDI-DI
90841732128111 FDA UDI
510(k) Number
K091278 FDA UDI
FDA Product Code
ODP FDA UDI
MAX FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Valeo by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K091278 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CTL Medical Corporation

Sources (1)

  • FDA UDI 6a5d75dd-d31b-41db-8306-7ed8331e5bfc 35 fields · synced Jun 1, 2026