Identity
- Trade Name
- MySpine Unilateral Guide FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MySpine Unilateral left guide T03 STERILE FDA UDI
- Model / Reference
- 7.1003S FDA UDI
- Description
- MySpine Unilateral left guide T03 STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345786258 FDA UDI
- 510(k) Number
- K231483 FDA UDI
- FDA Product Code
- PQC FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
MySpine Unilateral Guide by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
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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 (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 6169599a-44db-463c-b60b-ac2f1c99bcbb 34 fields · synced Jun 1, 2026