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Femoral Epidrill
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 12115NRef 32120NRef 52115NRef 52120Ref 32125Ref 12120Ref 32129NRef 52120NRef 42115
Identity
- Trade Name
- Epidrill EUDAMEDFemoral Epidrill FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- Epidrill EUDAMED
- Model / Reference
- 12115N EUDAMED32120N EUDAMED52115N EUDAMED52120 EUDAMED32125 EUDAMED12120 EUDAMED32129N EUDAMED52120N EUDAMED42115 EUDAMED2xD20 FDA UDI
Identifiers
- Catalog Number
- 52120PF FDA UDI
- Primary DI / UDI-DI
- +EPIS12115N0 EUDAMED+EPIS32120N0 EUDAMED+EPIS52115N0 EUDAMED+EPIS521200 EUDAMED+EPIS321250 EUDAMED+EPIS121200 EUDAMED+EPIS32129N0 EUDAMED+EPIS52120N0 EUDAMED+EPIS421150 EUDAMEDEPIS52120PF0 FDA UDI
- Basic UDI-DI
- B-+EPIS12115N0 EUDAMEDB-+EPIS32120N0 EUDAMEDB-+EPIS52115N0 EUDAMEDB-+EPIS521200 EUDAMEDB-+EPIS321250 EUDAMEDB-+EPIS121200 EUDAMEDB-+EPIS32129N0 EUDAMEDB-+EPIS52120N0 EUDAMEDB-+EPIS421150 EUDAMED
- 510(k) Number
- K221048 FDA UDI
- FDA Product Code
- KRR FDA UDI
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE 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 EUDAMEDBelgium EUDAMEDDenmark EUDAMEDGermany EUDAMEDSweden EUDAMEDNorway 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 Epidrill 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
- Dekalb Knee Pack — PACKROOM LLC
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Episurf Operations AB
Sources (10)
- FDA UDI 3e54205c-5caf-4d1e-b39a-dc595109b992 34 fields · synced Jul 27, 2026
- EUDAMED 3d8b51bb-8280-4570-9d09-20923322d28a 61 fields · synced Jul 9, 2026
- EUDAMED 0a97e137-4b4d-4bab-8d23-f998037218d5 61 fields · synced Jul 9, 2026
- EUDAMED 5f9edc80-897d-49dd-bae9-53f6d25f6405 61 fields · synced Jul 11, 2026
- EUDAMED 8ba8ce32-43ce-47dc-a37d-c2503e1fa3bb 61 fields · synced Jul 14, 2026
- EUDAMED 69bfd4c5-7b72-4a2b-b4fe-e7aae9ef4e0c 61 fields · synced Jul 14, 2026
- EUDAMED 8cb728a0-b192-4cd4-9581-a4722c615c70 61 fields · synced Jul 17, 2026
- EUDAMED b10fe842-5859-43b1-8cec-61fe085c1fc9 61 fields · synced Jul 18, 2026
- EUDAMED e2cb3b42-cca5-4752-bee7-2c5f957d4f33 61 fields · synced Jul 21, 2026
- EUDAMED 76cf1366-c3ea-4a1c-b916-598e44b29db8 61 fields · synced Jul 27, 2026