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Balanced Knee Revision System

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name
Balanced Knee Revision System FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
Offset Tibial Tray Sz 4 FDA UDI
Model / Reference
562-3400A FDA UDI
Description
Offset Tibial Tray Sz 4 FDA UDI

Identifiers

Primary DI / UDI-DI
00822409040308 FDA UDI
510(k) Number
K031201 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Uncoated knee tibia prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 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

Category: Uncoated knee tibia prosthesis, metallic

Balanced Knee Revision System by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee tibia prosthesis, metallic.

Cleared under the same submission

K031201 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA UDI 3801641a-38ae-4401-8136-e0d1996dfbfc 35 fields · synced Jun 1, 2026