Identity
- Trade Name
- Legion FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- OVAL PATELLA PROTECTOR SZ 41 FDA UDI
- Model / Reference
- E0014844-8 FDA UDI
- Description
- OVAL PATELLA PROTECTOR SZ 41 FDA UDI
Identifiers
- Catalog Number
- E0014844-8 FDA UDI
- Primary DI / UDI-DI
- 00885556654996 FDA UDI
- 510(k) Number
- K121393 FDA UDI
- FDA Product Code
- MBH FDA UDI
- GMDN Term
- Surgical instrument guard, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument guard, reusable
A comprehensive medical device for protecting surgical instruments and patients from injury during procedures, handling, and storage. The Legion prosthetic is a reusable device designed to be applied to a variety of surgical or invasive instruments.
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Cleared under the same submission
K121393 also covers:
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GII — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- JOURNEY — Smith & Nephew, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 596ef14c-8cf4-4a8d-ac06-e6b7c3a8cb62 36 fields · synced Jul 17, 2026