Identity
- Trade Name
- SAMBA SCREW SYSTEM FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- Torx Bit T-Handle FDA UDI
- Model / Reference
- 11-1109-FD17 FDA UDI
- Description
- Torx Bit T-Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- M364111109FD170 FDA UDI
- 510(k) Number
- K121148 FDA UDI
- FDA Product Code
- OUR FDA UDIHWC FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Samba Screw System by Medical Designs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sacroiliac joint transarticular fixation/arthrodesis implantation kit.
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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 1b4e135f-ce96-4283-bd02-637e7aecd7ba 34 fields · synced Jun 8, 2026