Identity
- Trade Name
- ESOP® FDA UDI
- Generic Name
- Coated hip femur prosthesis, modular FDA UDI
- Model / Reference
- 256238 - DIAPHYSEAL TIP, Ø11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489562389 FDA UDI
- 510(k) Number
- K021108 FDA UDI
- FDA Product Code
- MEH FDA UDI
- GMDN Term
- Coated hip femur prosthesis, modular 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coated hip femur prosthesis, modular
Esop® by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated hip femur prosthesis, modular.
- LCU Hip Stem — WALDEMAR LINK GmbH & Co. KG · Class II
- ABG — Howmedica Osteonics Corp. · Class II
- Z1™ Hip System — Zimmer, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- VerSys® — Zimmer, Inc. · Class II
- CATALYSTEM — Smith & Nephew, Inc. · Class II
- Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Excia® L — AESCULAP, INC. · Class II
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 382e2acc-9ceb-48a1-ba6b-e20b02140fae 33 fields · synced Jun 1, 2026