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Femoral Epiguide
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 33725NRef 53715NRef 13712NRef 13712Ref 53717Ref 13715NRef 53725NRef 53720Ref 43715Ref 13720NRef 33729NRef 33720Ref 33720NRef 53717NRef 53715Ref 33725Ref 13717NRef 13720
Identity
- Trade Name
- Epiguide EUDAMEDFemoral Epiguide FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- Epiguide EUDAMED
- Model / Reference
- 33725N EUDAMED53715N EUDAMED13712N EUDAMED13712 EUDAMED53717 EUDAMED13715N EUDAMED53725N EUDAMED53720 EUDAMED43715 EUDAMED13720N EUDAMED33729N EUDAMED33720 EUDAMED33720N EUDAMED53717N EUDAMED53715 EUDAMED33725 EUDAMED13717N EUDAMED13720 EUDAMEDD20 FDA UDI
Identifiers
- Catalog Number
- 33720PF FDA UDI
- Primary DI / UDI-DI
- +EPIS33725N0 EUDAMED+EPIS53715N0 EUDAMED+EPIS13712N0 EUDAMED+EPIS137120 EUDAMED+EPIS537170 EUDAMED+EPIS13715N0 EUDAMED+EPIS53725N0 EUDAMED+EPIS537200 EUDAMED+EPIS437150 EUDAMED+EPIS13720N0 EUDAMED+EPIS33729N0 EUDAMED+EPIS337200 EUDAMED+EPIS33720N0 EUDAMED+EPIS53717N0 EUDAMED+EPIS537150 EUDAMED+EPIS337250 EUDAMED+EPIS13717N0 EUDAMED+EPIS137200 EUDAMEDEPIS33720PF0 FDA UDI
- Basic UDI-DI
- B-+EPIS33725N0 EUDAMEDB-+EPIS53715N0 EUDAMEDB-+EPIS13712N0 EUDAMEDB-+EPIS137120 EUDAMEDB-+EPIS537170 EUDAMEDB-+EPIS13715N0 EUDAMEDB-+EPIS53725N0 EUDAMEDB-+EPIS537200 EUDAMEDB-+EPIS437150 EUDAMEDB-+EPIS13720N0 EUDAMEDB-+EPIS33729N0 EUDAMEDB-+EPIS337200 EUDAMEDB-+EPIS33720N0 EUDAMEDB-+EPIS53717N0 EUDAMEDB-+EPIS537150 EUDAMEDB-+EPIS337250 EUDAMEDB-+EPIS13717N0 EUDAMEDB-+EPIS137200 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 EUDAMEDDenmark EUDAMEDPoland EUDAMEDGermany EUDAMEDNorway EUDAMEDBelgium 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 Epiguide by Episurf Operations AB — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, single-use.
- OvertureTi — OVERTURE ORTHOPAEDICS
- Identity Imprint Knee Replacement System — Conformis, Inc. · Class II
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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 (19)
- FDA UDI 47d42215-a99a-46da-9217-58d640d24f8f 34 fields · synced Sep 17, 2026
- EUDAMED cb35eda3-dced-4402-8293-6df10c8f1174 61 fields · synced Jun 20, 2026
- EUDAMED bf667191-6141-4fb8-a44b-f5d9463e0739 61 fields · synced Jul 8, 2026
- EUDAMED c3da0a9b-951c-4173-bf3f-b148199752ba 61 fields · synced Jul 8, 2026
- EUDAMED 9b26aa20-16cf-4079-8270-19f27a045a80 61 fields · synced Jul 9, 2026
- EUDAMED 76df5a63-4ad8-447a-93f5-3b5b022b43f3 61 fields · synced Jul 11, 2026
- EUDAMED 5daf0b4b-5862-47e4-a357-5b8dce27721d 61 fields · synced Jul 13, 2026
- EUDAMED 124eda26-e23f-4e6a-9fcc-d7a3e8896993 61 fields · synced Jul 15, 2026
- EUDAMED eacf43fc-af28-4148-8702-7be3e9fb1eb5 61 fields · synced Jul 15, 2026
- EUDAMED 6bd48b8f-3b19-45be-b433-974950064be1 61 fields · synced Jul 16, 2026
- EUDAMED 509ca66e-726f-4409-96aa-76e6252886c0 61 fields · synced Jul 19, 2026
- EUDAMED 4c703c45-5f9b-4b05-8bb0-c0334afc4833 61 fields · synced Jul 23, 2026
- EUDAMED 7ae78457-faf2-46d3-81fd-416d9c7b7d64 61 fields · synced Jul 24, 2026
- EUDAMED 11931797-0236-432a-8459-fd47a31d09a5 61 fields · synced Jul 26, 2026
- EUDAMED 52848472-29d5-4e03-97da-64459b001b14 61 fields · synced Jul 29, 2026
- EUDAMED 84b5bd55-56ee-4f33-ba45-a2c7a0b6bd6c 61 fields · synced Jul 29, 2026
- EUDAMED 8bc49913-cba5-400d-acca-2a2fbbcf27d5 61 fields · synced Aug 1, 2026
- EUDAMED da2d6ba4-7bf6-46bc-8c92-a505b107f807 61 fields · synced Aug 1, 2026
- EUDAMED f49a8624-a2eb-48a2-8f23-fd282f57392d 61 fields · synced Sep 17, 2026