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Femoral Drilling Socket
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 13117Ref 13117NRef 13115Ref 53115Ref 43115NRef 33129Ref 13120Ref 53120NRef 53125NRef 53117Ref 13112Ref 13115NRef 43115Ref 13120N
Identity
- Trade Name
- Drilling Socket EUDAMEDFemoral Drilling Socket FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- Drilling Socket EUDAMED
- Model / Reference
- 13117 EUDAMED13117N EUDAMED13115 EUDAMED53115 EUDAMED43115N EUDAMED33129 EUDAMED13120 EUDAMED53120N EUDAMED53125N EUDAMED53117 EUDAMED13112 EUDAMED13115N EUDAMED43115 EUDAMED13120N EUDAMEDD29 FDA UDI
Identifiers
- Catalog Number
- 33129PF FDA UDI
- Primary DI / UDI-DI
- +EPIS131170 EUDAMED+EPIS13117N0 EUDAMED+EPIS131150 EUDAMED+EPIS531150 EUDAMED+EPIS43115N0 EUDAMED+EPIS331290 EUDAMED+EPIS131200 EUDAMED+EPIS53120N0 EUDAMED+EPIS53125N0 EUDAMED+EPIS531170 EUDAMED+EPIS131120 EUDAMED+EPIS13115N0 EUDAMED+EPIS431150 EUDAMED+EPIS13120N0 EUDAMEDEPIS33129PF0 FDA UDI
- Basic UDI-DI
- B-+EPIS131170 EUDAMEDB-+EPIS13117N0 EUDAMEDB-+EPIS131150 EUDAMEDB-+EPIS531150 EUDAMEDB-+EPIS43115N0 EUDAMEDB-+EPIS331290 EUDAMEDB-+EPIS131200 EUDAMEDB-+EPIS53120N0 EUDAMEDB-+EPIS53125N0 EUDAMEDB-+EPIS531170 EUDAMEDB-+EPIS131120 EUDAMEDB-+EPIS13115N0 EUDAMEDB-+EPIS431150 EUDAMEDB-+EPIS13120N0 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 EUDAMEDPoland EUDAMEDDenmark EUDAMEDGermany EUDAMEDNorway EUDAMEDSweden 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 Drilling Socket 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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- 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 (15)
- FDA UDI a1cc9f31-4ae8-4df3-98ff-f441b79410da 34 fields · synced Aug 3, 2026
- EUDAMED a04c6411-4198-4b27-9b1e-4219fa19cf1f 61 fields · synced Jul 10, 2026
- EUDAMED 0becfb3f-de38-46bc-a93a-73222ce51e73 61 fields · synced Jul 12, 2026
- EUDAMED d1fc71b7-3846-40ef-bd5f-70adc3bafde6 61 fields · synced Jul 12, 2026
- EUDAMED 027efbf9-9900-4e99-8223-232c2a40a25f 61 fields · synced Jul 12, 2026
- EUDAMED a1e827b6-27d8-498b-bcd2-54333bb4077d 61 fields · synced Jul 14, 2026
- EUDAMED 057742bd-744d-4262-87e0-8f4ca8938287 61 fields · synced Jul 17, 2026
- EUDAMED 5f448d15-c5eb-48d4-825d-4de38b501065 61 fields · synced Jul 17, 2026
- EUDAMED 17d10b96-9b8a-41f4-9feb-6db6e7e3cb81 61 fields · synced Jul 18, 2026
- EUDAMED 21c1e5f7-d729-4ed5-a923-26985a1defc4 61 fields · synced Jul 21, 2026
- EUDAMED 7e805afa-6a97-4632-84dd-e7e3fcfb5d83 61 fields · synced Jul 23, 2026
- EUDAMED 8a95b0c4-7868-4140-886e-b197a692c1cb 61 fields · synced Jul 27, 2026
- EUDAMED 1212bf26-e24c-49a1-be13-7d5f082fc7de 61 fields · synced Jul 28, 2026
- EUDAMED 782c93c1-5541-4013-a4c1-91417243a89c 61 fields · synced Jul 29, 2026
- EUDAMED 5a4fec8b-d78e-4182-9a7f-5ec6413f2d00 61 fields · synced Aug 3, 2026