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Femoral Adjustment Socket
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 33420NRef 33420Ref 33429NRef 43415NRef 53420Ref 43415Ref 13417NRef 13412Ref 53417NRef 13415
Identity
- Trade Name
- Adjustment Socket EUDAMEDFemoral Adjustment Socket FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- Adjustment Socket EUDAMED
- Model / Reference
- 33420N EUDAMED33420 EUDAMED33429N EUDAMED43415N EUDAMED53420 EUDAMED43415 EUDAMED13417N EUDAMED13412 EUDAMED53417N EUDAMED13415 EUDAMEDD25 FDA UDI
Identifiers
- Catalog Number
- 33425PF FDA UDI
- Primary DI / UDI-DI
- +EPIS33420N0 EUDAMED+EPIS334200 EUDAMED+EPIS33429N0 EUDAMED+EPIS43415N0 EUDAMED+EPIS534200 EUDAMED+EPIS434150 EUDAMED+EPIS13417N0 EUDAMED+EPIS134120 EUDAMED+EPIS53417N0 EUDAMED+EPIS134150 EUDAMEDEPIS33425PF0 FDA UDI
- Basic UDI-DI
- B-+EPIS33420N0 EUDAMEDB-+EPIS334200 EUDAMEDB-+EPIS33429N0 EUDAMEDB-+EPIS43415N0 EUDAMEDB-+EPIS534200 EUDAMEDB-+EPIS434150 EUDAMEDB-+EPIS13417N0 EUDAMEDB-+EPIS134120 EUDAMEDB-+EPIS53417N0 EUDAMEDB-+EPIS134150 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
- Belgium EUDAMEDGermany EUDAMEDSweden EUDAMEDPoland 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 Adjustment Socket 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.
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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 Component — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Episurf Operations AB
Sources (11)
- FDA UDI 6d3634b7-6da6-4233-b5c2-809dbf178ed8 34 fields · synced Sep 18, 2026
- EUDAMED 77a8fad8-45ae-4841-ad5c-827e020c9104 61 fields · synced Jul 10, 2026
- EUDAMED bebd45a7-4795-4e15-b493-4da926622b96 61 fields · synced Jul 12, 2026
- EUDAMED e1d0b558-5c4d-4510-9eef-82694a99690e 61 fields · synced Jul 12, 2026
- EUDAMED 08eddf76-4dd6-4efe-b20c-222111e40062 61 fields · synced Jul 14, 2026
- EUDAMED 68ca8587-fa4a-4333-8529-9bfe32fa2978 61 fields · synced Jul 20, 2026
- EUDAMED d83be273-4ce7-4eb0-a0bc-f75f66376ab0 61 fields · synced Jul 22, 2026
- EUDAMED e1ed88aa-3f18-4121-9778-62961b9715c3 61 fields · synced Jul 30, 2026
- EUDAMED 9dc8cabf-4eed-49c8-b96d-4dbd5c51c46a 61 fields · synced Jul 31, 2026
- EUDAMED f285451f-6da8-4a14-ade3-89e582045d37 61 fields · synced Jul 31, 2026
- EUDAMED 6de5aa70-c499-4b3e-95c0-bc289730ee06 61 fields · synced Sep 18, 2026