Identity
- Trade Name
- SambaScrew FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI
- Device Name
- 9mm x 30mm SambaScrew FDA UDI
- Model / Reference
- 11-1109-2 FDA UDI
- Description
- 9mm x 30mm SambaScrew FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18257200119189 FDA UDI
- 510(k) Number
- K121148 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Millimeter FDA UDIWidth — 9 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile
SambaScrew by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile.
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- ZESPIN SI Joint Fusion System — Aegis Spine, Inc. · Class II
- CATAMARAN™ SIJ Fusion System — Tenon Medical · Class II
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- Orion Sacroiliac Joint Fusion System — Pantheon Spinal LLC · Class II
- Zavation — ZAVATION · Class II
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
Cleared under the same submission
K121148 also covers:
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC
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
- Orthofix US LLC
Sources (1)
- FDA UDI 50f05847-1671-4330-a709-fec2072db2c1 35 fields · synced May 31, 2026