Identity
- Trade Name
- My Spine Pedicle Screw Placement Guides FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MySpine drill guide T05 STERILE FDA UDI
- Model / Reference
- 7.0105S FDA UDI
- Description
- MySpine drill guide T05 STERILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030856525 FDA UDI
- 510(k) Number
- K132788 FDA UDI
- FDA Product Code
- MNI 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
My Spine Pedicle Screw Placement Guides 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
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left — Orthosoft Inc · Class II
- MyKnee PPS — Medacta International · Class II
Cleared under the same submission
K132788 also covers:
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — Medacta International
- My Spine Pedicle Screw Placement Guides — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI 780ec85b-e298-477a-a36f-7d364c04718c 34 fields · synced May 30, 2026