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OPRA Implant System

FDA UDI

Class III (US FDA UDI)

by Integrum AB

Identity

Trade Name
OPRA Implant System FDA UDI
Generic Name
Internal-external leg prosthesis osseointegration bar FDA UDI
Device Name
Healing Screw A0 FDA UDI
Model / Reference
1354 FDA UDI
Description
Healing Screw A0 FDA UDI

Identifiers

Catalog Number
1354 FDA UDI
Primary DI / UDI-DI
07340152100535 FDA UDI
PMA Number
H080004 FDA UDI
FDA Product Code
PJY FDA UDI
GMDN Term
Internal-external leg prosthesis osseointegration bar FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Internal-external leg prosthesis osseointegration bar

OPRA Implant System by Integrum AB — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal-external leg prosthesis osseointegration bar.

Cleared under the same submission

H080004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integrum AB

Sources (1)

  • FDA UDI a011f3e9-1de1-4020-a2a3-44a4697fa0df 36 fields · synced May 31, 2026