Identity
- Trade Name
- Klassic Tibial Insert, CR/Congruent, E-Link Poly FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Tibial Insert, CR/Congruent, E-Link Poly, size 3, 14mm FDA UDI
- Model / Reference
- 5302.03.014 FDA UDI
- Description
- Tibial Insert, CR/Congruent, E-Link Poly, size 3, 14mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703014116 FDA UDI
- 510(k) Number
- K180159 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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
Ethylene Oxide FDA UDI
Category: Tibial insert
Klassic Tibial Insert, CR/Congruent, E-Link Poly by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180159 also covers:
- Klassic Domed Patella with E-Link — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Domed Patella with E-Link — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Sombrero Patella with E-Link — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Sombrero Patella with E-Link — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Sombrero Patella with E-Link — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Tibial Insert, CR/Congruent, E-Link Poly — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Tibial Insert, CR/Congruent, E-Link Poly — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Tibial Insert, CR/Congruent, E-Link Poly — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Tibial Insert, CR/Congruent, E-Link Poly — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Tibial Insert, CR/Congruent, E-Link Poly — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Tibial Insert, CR/Congruent, E-Link Poly — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic Tibial Insert, CR/Congruent, E-Link Poly — 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 f3d5c0a6-712b-4fc6-a1d9-1f88f711b6fe 37 fields · synced May 30, 2026