Identity
- Trade Name
- LIS FEMORAL ELEVATOR FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- 254617 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489546174 FDA UDI
- 510(k) Number
- K021108 FDA UDI
- FDA Product Code
- MEH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Lis Femoral Elevator by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K021108 also covers:
- ANT BROACH HANDLE DIA 8/13 — FOURNITURES HOSPITALIERES INDUSTRIE
- ANTERIOR AUTOSTATIC RETRACTOR — FOURNITURES HOSPITALIERES INDUSTRIE
- CHARNLEY SHORT FRAME — FOURNITURES HOSPITALIERES INDUSTRIE
- DIAPHYSARY TRIAL SHAFT ESOP DIAMETER 14 — FOURNITURES HOSPITALIERES INDUSTRIE
- DRILL GUIDE DIAMETRE 4.5 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP BROACH D8 LEFT S 10 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP BROACH D8 LEFT S 11, 25 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP BROACH D8 LEFT S 15 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP BROACH D8 LEFT S 7, 5 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP BROACH D8 RIGHT S 11, 25 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP HA SIZER Ø10 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP HA SIZER Ø11 — FOURNITURES HOSPITALIERES INDUSTRIE
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
- Fournitures Hospitalieres Industrie
Sources (1)
- FDA UDI 33bd6a2b-8881-43b7-8f00-b2b4e4d38836 33 fields · synced May 31, 2026