Identity
- Trade Name
- EXULT Knee Replacement System FDA UDI
- Generic Name
- Patella prosthesis trial FDA UDI
- Device Name
- Patella Trial – B type 34X10mm FDA UDI
- Model / Reference
- 01.62.9AC-PPX FDA UDI
- Description
- Patella Trial – B type 34X10mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800068942180 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Patella prosthesis trial 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Patella prosthesis trial
EXULT Knee Replacement System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patella prosthesis trial.
- Unity Knee System — OMNIlife science, Inc. · Class I
- BIOMET SERIES A — Biomet Orthopedics, Inc. · Class II
- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I
- LCS — DEPUY ORTHOPAEDICS, INC. · Class I
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
- Corentec Co., Ltd
Sources (1)
- FDA UDI 59d761c4-d6e3-454d-aa4e-f18bd22aaf91 34 fields · synced May 30, 2026