Identity
- Trade Name
- Truliant FDA UDI
- Generic Name
- Trabeculated knee tibia/insert prosthesis FDA UDI
- Device Name
- Truliant Porous Tibial Tray FDA UDI
- Model / Reference
- 02-022-55-0010 FDA UDI
- Description
- Truliant Porous Tibial Tray FDA UDI
Identifiers
- Catalog Number
- 02-022-55-0010 FDA UDI
- Primary DI / UDI-DI
- 10885862316998 FDA UDI
- 510(k) Number
- K182346 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDI
- GMDN Term
- Trabeculated knee tibia/insert prosthesis 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Trabeculated knee tibia/insert prosthesis
Truliant by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trabeculated knee tibia/insert prosthesis.
- NEXGEN® — Zimmer, Inc. · Class II
- NEXGEN® — Zimmer, Inc. · Class II
- NEXGEN® — Zimmer, Inc. · Class II
- NEXGEN® — Zimmer, Inc. · Class II
- NEXGEN® — Zimmer, Inc. · Class II
- NEXGEN® — Zimmer, Inc. · Class II
- NEXGEN® — Zimmer, Inc. · Class II
- NEXGEN® — Zimmer, Inc. · Class II
Cleared under the same submission
K182346 also covers:
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, Inc.
- Truliant — Exactech, 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
- Exactech, Inc.
Sources (1)
- FDA UDI 445d80ab-54d7-45f7-bbc3-c5894de43f8b 36 fields · synced May 30, 2026