← Back to catalogue

Proview

FDA UDI

Class I (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name
PROVIEW FDA UDI
Generic Name
Growth-correction orthopaedic fixation plate kit FDA UDI
Device Name
ONYX INSTRUMENTATION SET CASE 2 FDA UDI
Model / Reference
70-1091 FDA UDI
Description
ONYX INSTRUMENTATION SET CASE 2 FDA UDI

Identifiers

Primary DI / UDI-DI
18257200065677 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Growth-correction orthopaedic fixation plate kit 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Growth-correction orthopaedic fixation plate kit

Proview by Orthofix US LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Growth-correction orthopaedic fixation plate kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orthofix US LLC

Sources (1)

  • FDA UDI f2f9d32a-5e6e-475d-9e6a-e4d4a9cb93d2 34 fields · synced May 31, 2026