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Klassic Tibial Baseplate, Revision

FDA UDI

Class II (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name
Klassic Tibial Baseplate, Revision FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
Tibial Baseplate Assembly, Revision, Sz 6 This contains the following implant numbers: 6200.06.000 Klassic Tibial Baseplate, Revision, Sz 6 (00810094701291) & 5603.00.000 Klassic Tibial Insert Set Screw for Primary or Revision (00814703012754) FDA UDI
Model / Reference
6201.06.000 FDA UDI
Description
Tibial Baseplate Assembly, Revision, Sz 6 This contains the following implant numbers: 6200.06.000 Klassic Tibial Baseplate, Revision, Sz 6 (00810094701291) & 5603.00.000 Klassic Tibial Insert Set Screw for Primary or Revision (00814703012754) FDA UDI

Identifiers

Primary DI / UDI-DI
00810094701352 FDA UDI
510(k) Number
K243991 FDA UDI
FDA Product Code
JWH FDA UDI
OIY 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
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Uncoated knee tibia prosthesis, metallic

Klassic Tibial Baseplate, Revision by Total Joint Orthopedics, Inc. — 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

K243991 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Total Joint Orthopedics, Inc.

Sources (1)

  • FDA UDI 23e4781d-459f-4ca0-b466-a4895c15ed73 37 fields · synced May 31, 2026