MySpine Unilateral Guide
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MySpine Unilateral right guide L01 EUDAMEDMySpine Unilateral Guide FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MySpine Unilateral right guide L01 FDA UDI
- Model / Reference
- 7.1051 EUDAMEDFDA UDISpine Drill guide - not sterile EUDAMED
- Description
- MySpine Unilateral right guide L01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345786883 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VSP0142N00KS EUDAMED
- 510(k) Number
- K231483 FDA UDI
- FDA Product Code
- PQC 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
- 888.3070 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
MySpine Unilateral Guide by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
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- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left — Orthosoft Inc · Class II
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Cleared under the same submission
K231483 also covers:
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
- MySpine Unilateral Guide — Medacta International
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
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Manufacturer
- Manufacturer
- Medacta International
Sources (2)
- FDA UDI d7dd257d-8f6d-4046-b23a-c2d4320e8d12 34 fields · synced Oct 8, 2026
- EUDAMED a6d91756-1768-4078-947c-4986aad5be82 61 fields · synced Oct 8, 2026