Identity
- Trade Name
- Klassic Knee Tibial Stem Extension, 100mm FDA UDI
- Generic Name
- Knee tibia stem prosthesis FDA UDI
- Model / Reference
- 5600.00.100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703011498 FDA UDI
- 510(k) Number
- K140942 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee tibia stem prosthesis 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
Radiation Sterilization FDA UDI
Category: Knee tibia stem prosthesis
Klassic Knee Tibial Stem Extension, 100mm by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee tibia stem prosthesis.
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K140942 also covers:
- Klassic Knee Tibial Stem Extension, 125mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Knee Tibial Stem Extension, 150mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Knee Tibial Stem Extension, 25mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Knee Tibial Stem Extension, 50mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Knee Tibial Stem Extension, 75mm — TOTAL JOINT ORTHOPEDICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI fab95cea-5802-4a2f-9c45-e68c245125df 36 fields · synced Jun 8, 2026