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Paragon 28 Bone Wedge System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name
Paragon 28 Bone Wedge System FDA UDI
Generic Name
Metallic osteotomy fusion cage, non-customized FDA UDI
Device Name
AO ORGANIC COTTON BONE SEG 16 X 7 FDA UDI
Model / Reference
AOCWO-16-7 FDA UDI
Description
AO ORGANIC COTTON BONE SEG 16 X 7 FDA UDI

Identifiers

Catalog Number
AOCWO-16-7 FDA UDI
Primary DI / UDI-DI
00889795120212 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Metallic osteotomy fusion cage, non-customized

Paragon 28 Bone Wedge System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI cb61b73b-d296-4ea2-837d-7035d9c27703 34 fields · synced May 30, 2026