Identity
- Trade Name
- Advanced MyHip Planner FDA UDI
- Generic Name
- Orthopaedic/craniofacial implantation planning software FDA UDI
- Device Name
- MICROSOFT SurfacePro7 - Planner/Verifier FDA UDI
- Model / Reference
- 5.3SWSUR FDA UDI
- Description
- MICROSOFT SurfacePro7 - Planner/Verifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630542715679 FDA UDI
- 510(k) Number
- K221725 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Orthopaedic/craniofacial implantation planning software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic/craniofacial implantation planning software
Advanced MyHip Planner by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic/craniofacial implantation planning software.
- OrthoView — Meridian Technique, Ltd. · Class II
- OrthoView — Meridian Technique, Ltd. · Class II
- OrthoView — Meridian Technique, Ltd. · Class II
- OrthoView — Meridian Technique, Ltd. · Class II
- hipEOS — Onefit Medical · Class II
- OrthoView — Meridian Technique, Ltd. · Class II
- OrthoView — Meridian Technique, Ltd. · Class II
- VEA — ALPHATEC SPINE, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI af30c348-8583-44a1-84e2-7c04e45c2d4a 34 fields · synced May 30, 2026