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Femoral Epimandrel
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 17312Ref 37329NRef 37320Ref 17317Ref 37325Ref 47115NRef 57325Ref 47115Ref 57315NRef 57320Ref 57317NRef 37325N
Identity
- Trade Name
- Epimandrel EUDAMEDFemoral Epimandrel FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- Epimandrel EUDAMED
- Model / Reference
- 17312 EUDAMED37329N EUDAMED37320 EUDAMED17317 EUDAMED37325 EUDAMED47115N EUDAMED57325 EUDAMED47115 EUDAMED57315N EUDAMED57320 EUDAMED57317N EUDAMED37325N EUDAMEDD25 FDA UDI
Identifiers
- Catalog Number
- 37325PF FDA UDI
- Primary DI / UDI-DI
- +EPIS173120 EUDAMED+EPIS37329N0 EUDAMED+EPIS373200 EUDAMED+EPIS173170 EUDAMED+EPIS373250 EUDAMED+EPIS47115N0 EUDAMED+EPIS573250 EUDAMED+EPIS471150 EUDAMED+EPIS57315N0 EUDAMED+EPIS573200 EUDAMED+EPIS57317N0 EUDAMED+EPIS37325N0 EUDAMEDEPIS37325PF0 FDA UDI
- Basic UDI-DI
- B-+EPIS173120 EUDAMEDB-+EPIS37329N0 EUDAMEDB-+EPIS373200 EUDAMEDB-+EPIS173170 EUDAMEDB-+EPIS373250 EUDAMEDB-+EPIS47115N0 EUDAMEDB-+EPIS573250 EUDAMEDB-+EPIS471150 EUDAMEDB-+EPIS57315N0 EUDAMEDB-+EPIS573200 EUDAMEDB-+EPIS57317N0 EUDAMEDB-+EPIS37325N0 EUDAMED
- 510(k) Number
- K221048 FDA UDI
- FDA Product Code
- KRR FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Joint prosthesis implantation kit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3540 FDA UDI
- Market of Registration
- Sweden EUDAMEDGermany EUDAMEDBelgium EUDAMEDDenmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Joint prosthesis implantation kit, single-use
Femoral Epimandrel by Episurf Operations AB — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Joint prosthesis implantation kit, single-use.
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- IDENTITY IMPRINT — Conformis, Inc. · Class II
- Argo Knotless — Conmed Corporation · Class IIa
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Cleared under the same submission
K221048 also covers:
- Episealer Knee Revision Guide — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Episurf Operations AB
Sources (13)
- FDA UDI 59a9ceb1-8366-4fa5-8bff-7da917ef3082 34 fields · synced Jul 30, 2026
- EUDAMED 085148e0-5956-4734-ad40-22c3fc4d6617 61 fields · synced Jun 20, 2026
- EUDAMED 7a5024ce-937b-4ef6-a3ab-ef001eb31005 61 fields · synced Jun 20, 2026
- EUDAMED ac2d9d19-2d7b-4f7e-8f91-1259893b5a3c 61 fields · synced Jul 9, 2026
- EUDAMED ad3ff442-1e33-40a0-9e36-fa9ab2afec38 61 fields · synced Jul 10, 2026
- EUDAMED a7c827b0-6e34-4560-a4fb-8709b6acb43f 61 fields · synced Jul 10, 2026
- EUDAMED 4231de26-c51e-4e62-b147-3f033cee912a 61 fields · synced Jul 14, 2026
- EUDAMED ee2f0223-da4d-4a80-b593-0421ad044fc9 61 fields · synced Jul 16, 2026
- EUDAMED b6409daa-1deb-4e9e-a26e-daa3955052dd 61 fields · synced Jul 16, 2026
- EUDAMED 31bbfe80-f4e3-4131-868a-dee4ed111a98 61 fields · synced Jul 17, 2026
- EUDAMED ee553342-0570-4ca8-bdb0-0d2caea0e62b 61 fields · synced Jul 22, 2026
- EUDAMED 32ae3c32-7fbe-4c59-b70a-ae58e3a2b939 61 fields · synced Jul 29, 2026
- EUDAMED 4ecb2e33-6d7f-4953-b428-70dfe6d55db2 61 fields · synced Jul 30, 2026