Identity
- Trade Name
- ORTHOLOC® FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Device Name
- ORTHOLOC® II PLASTIC PATELLA 35mm, MD, LG, X-LG FDA UDI
- Model / Reference
- 18450244 FDA UDI
- Description
- ORTHOLOC® II PLASTIC PATELLA 35mm, MD, LG, X-LG FDA UDI
Identifiers
- Catalog Number
- 18450244 FDA UDI
- Primary DI / UDI-DI
- M684184502441 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Polyethylene patella prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 35 Millimeter FDA UDI
Category: Polyethylene patella prosthesis
Ortholoc® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene patella prosthesis.
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- LEGION — Smith & Nephew, Inc. · Class II
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
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI f750cb92-57f2-4cfb-8ec4-5f80112e75a1 36 fields · synced Jun 9, 2026