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M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
- Device Name
- M.U.S.T. SI Ti-HA Joint screw 8x60 FDA UDI
- Model / Reference
- 03.65.508 FDA UDI
- Description
- M.U.S.T. SI Ti-HA Joint screw 8x60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030880889 FDA UDI
- 510(k) Number
- K193083 FDA UDI
- FDA Product Code
- OUR FDA UDIHWC FDA UDIHTN FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Sacroiliac joint transarticular fixation/arthrodesis implant, coated
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, coated.
- SImmetry Implant, 12.5mm x 100mm — Paradigm Spine, LLC · Class II
- iFuse Granite Implant System — Si-Bone Inc. · Class II
- SImmetry Implant, 14.5mm x 75mm — Paradigm Spine, LLC · Class II
- BowTie SI Fusion System — SAIL FUSION · Class II
- iFuse Bedrock Granite Implant System — Si-Bone Inc. · Class II
- SImmetry LAG Implant, 10.5mm x 105mm — Paradigm Spine, LLC · Class II
- SImmetry LAG Implant, 12.5mm x 90mm — Paradigm Spine, LLC · Class II
- iFuse TORQ Implant System — Si-Bone Inc. · Class II
Cleared under the same submission
K193083 also covers:
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — 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 8fb7529e-1def-4b43-9fab-d1284a38165c 34 fields · synced May 31, 2026