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Femoral Epidummy
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 14115NRef 44115Ref 54120Ref 14112NRef 14117Ref 54125NRef 34125NRef 34129NRef 54117Ref 34129Ref 54115NRef 54115Ref 34125
Identity
- Trade Name
- Epidummy EUDAMEDFemoral Epidummy FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- Epidummy EUDAMED
- Model / Reference
- 14115N EUDAMED44115 EUDAMED54120 EUDAMED14112N EUDAMED14117 EUDAMED54125N EUDAMED34125N EUDAMED34129N EUDAMED54117 EUDAMED34129 EUDAMED54115N EUDAMED54115 EUDAMED34125 EUDAMEDD20 FDA UDI
Identifiers
- Catalog Number
- 34120PF FDA UDI
- Primary DI / UDI-DI
- +EPIS14115N0 EUDAMED+EPIS441150 EUDAMED+EPIS541200 EUDAMED+EPIS14112N0 EUDAMED+EPIS141170 EUDAMED+EPIS54125N0 EUDAMED+EPIS34125N0 EUDAMED+EPIS34129N0 EUDAMED+EPIS541170 EUDAMED+EPIS341290 EUDAMED+EPIS54115N0 EUDAMED+EPIS541150 EUDAMED+EPIS341250 EUDAMEDEPIS34120PF0 FDA UDI
- Basic UDI-DI
- B-+EPIS14115N0 EUDAMEDB-+EPIS441150 EUDAMEDB-+EPIS541200 EUDAMEDB-+EPIS14112N0 EUDAMEDB-+EPIS141170 EUDAMEDB-+EPIS54125N0 EUDAMEDB-+EPIS34125N0 EUDAMEDB-+EPIS34129N0 EUDAMEDB-+EPIS541170 EUDAMEDB-+EPIS341290 EUDAMEDB-+EPIS54115N0 EUDAMEDB-+EPIS541150 EUDAMEDB-+EPIS341250 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
- Poland EUDAMEDGermany EUDAMEDSweden 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 Epidummy 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.
- OvertureTi — OVERTURE ORTHOPAEDICS
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- IDENTITY IMPRINT — Conformis, Inc. · Class II
- Argo Knotless — Conmed Corporation · Class IIa
- Instruments IIa — Newclip Technics SAS · Class IIa
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
- CC-Hook Right — Xiros Limited · Class IIa
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 (14)
- FDA UDI 6069d8cb-f2c0-47be-8fe4-0612c7f498d1 34 fields · synced Aug 3, 2026
- EUDAMED 9ae32307-e862-477b-b0a0-1caebb2e49cf 61 fields · synced Jul 8, 2026
- EUDAMED 4e411725-f542-412d-9bac-5668356deb16 61 fields · synced Jul 8, 2026
- EUDAMED fbbf5658-1cf7-43b7-92c7-988882436aad 61 fields · synced Jul 10, 2026
- EUDAMED 55b17a7e-a05e-413f-a2af-d6f88cb70fb3 61 fields · synced Jul 15, 2026
- EUDAMED 35f65664-7ba2-48a6-9add-8533ca8d0ea7 61 fields · synced Jul 16, 2026
- EUDAMED d33920bb-d8e8-4eb8-912a-83051036b333 61 fields · synced Jul 16, 2026
- EUDAMED a4159dcb-e330-43ba-88b1-bdef0bb4369f 61 fields · synced Jul 16, 2026
- EUDAMED 76438442-f5b7-4f2f-8e9a-a3f19e525c39 61 fields · synced Jul 22, 2026
- EUDAMED 2ea7c72e-512e-4d2a-9938-fc0263f021a3 61 fields · synced Jul 23, 2026
- EUDAMED d3103632-e326-43b2-aedb-9f70ed6789db 61 fields · synced Jul 24, 2026
- EUDAMED 82caecd1-f735-40ab-9953-d1c83259c1cd 61 fields · synced Jul 27, 2026
- EUDAMED 3fc042be-2d38-4a51-bd7d-476694399cb7 61 fields · synced Aug 1, 2026
- EUDAMED 6a28fff9-a3b9-463e-8c5f-3a947c6962c9 61 fields · synced Aug 3, 2026