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MyKnee NextAR Femur Distal Cutting Block Efficiency
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 16.2016MModel Knee Cutting guide NextAR - not sterile
Identity
- Trade Name
- MyKnee NextAR Eff FemDisCutBl_Ass-MRI-GMK-LM-#6+ EUDAMEDMyKnee NextAR Femur Distal Cutting Block Efficiency FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #6+ FDA UDI
- Model / Reference
- 16.2016M EUDAMEDFDA UDIKnee Cutting guide NextAR - not sterile EUDAMED
- Description
- MyKnee NextAR Femur Distal Cutting Block Efficiency – MRI - GMK - Left Medial - #6+ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630971276635 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274KSP0882N00E2 EUDAMED
- 510(k) Number
- K193559 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- K01020114 MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee NextAR Femur Distal Cutting Block Efficiency by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
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- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left — Orthosoft Inc · Class II
- MyKnee PPS — Medacta International · Class II
Cleared under the same submission
K193559 also covers:
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
- MyKnee NextAR Femur Distal Cutting Block Efficiency — Medacta International
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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
- Medacta International
Sources (2)
- FDA UDI 64a6faa8-d710-48a3-a30e-dcb8a1f975fa 34 fields · synced Oct 10, 2026
- EUDAMED 7e4df9c8-3ff0-47a3-9715-2b442eeb80b2 61 fields · synced Oct 10, 2026