Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Patella prosthesis trial FDA UDI
- Device Name
- INSERTER, PATELLA TYPE 2 FDA UDI
- Model / Reference
- 802-01-070 FDA UDI
- Description
- INSERTER, PATELLA TYPE 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912134958 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Patella prosthesis trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Patella prosthesis trial
Djo Surgical by Djo, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patella prosthesis trial.
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- EXULT Knee Replacement System — Corentec Co., Ltd · 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
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 I | Pending data |
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Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 46cd952b-51bd-42e0-bedb-79feb53ad1d7 33 fields · synced May 30, 2026