My Spine Low Profile Placement Guides
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MySpine LP guide T04 STERILE EUDAMEDMy Spine Low Profile Placement Guides FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MySpine LP guide T04 STERILE FDA UDI
- Model / Reference
- 7.0504S EUDAMEDFDA UDISpine Drill guide - sterile EUDAMED
- Description
- MySpine LP guide T04 STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030877834 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274VSP0142R00LE EUDAMED
- 510(k) Number
- K153273 FDA UDI
- FDA Product Code
- MNI 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
Yes
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
My Spine Low Profile Placement Guides 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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Cleared under the same submission
K153273 also covers:
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — Medacta International
- My Spine Low Profile Placement Guides — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medacta International
Sources (2)
- FDA UDI 1043d889-d4da-473e-8a71-c8b827a1517e 34 fields · synced Oct 9, 2026
- EUDAMED b0d491ca-1845-4b01-9a40-963eace0f304 61 fields · synced Oct 9, 2026