Identity
- Trade Name
- SAMBA® Screw System FDA UDI
- Generic Name
- Sacroiliac joint intra-articular arthrodesis implant FDA UDI
- Device Name
- 35mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients. FDA UDI
- Model / Reference
- 11-1109-FD3 FDA UDI
- Description
- 35mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M364111109FD30 FDA UDI
- 510(k) Number
- K121148 FDA UDI
- FDA Product Code
- OUR FDA UDIHWC FDA UDI
- GMDN Term
- Sacroiliac joint intra-articular arthrodesis implant 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 9 Millimeter FDA UDILength — 35 Millimeter FDA UDI
Category: Sacroiliac joint intra-articular arthrodesis implant
SAMBA® Screw System by Medical Designs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Designs Llc
Sources (1)
- FDA UDI 56859585-2174-43d0-85c1-4f74a475f334 36 fields · synced Jun 8, 2026