Identity
- Trade Name
- DYNAMIS™ Implant System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- DYNAMIS™ TRU-NANO SI SCREW, DIA 10.5 X 60MM FDA UDI
- Model / Reference
- SI10560-TN FDA UDI
- Description
- DYNAMIS™ TRU-NANO SI SCREW, DIA 10.5 X 60MM FDA UDI
Identifiers
- Catalog Number
- SI10560-TN FDA UDI
- Primary DI / UDI-DI
- 20810152101586 FDA UDI
- 510(k) Number
- K251075 FDA UDI
- FDA Product Code
- OUR FDA UDIHWC FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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 — 10.5 Millimeter FDA UDILength — 60 Millimeter FDA UDI
Category: Spinal bone screw, non-bioabsorbableSacroiliac joint transarticular fixation/arthrodesis implant, uncoated
DYNAMIS™ Implant System by Promethean Restorative — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated.
- SOLACE Sacroiliac Fixation System — Xenix Medical · Class II
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- Unity Erodium — Dio Medical Co., Ltd. · Class II
- PathLoc- SI Joint Fusion System — L&K BIOMED CO. , LTD. · Class II
- ZESPIN SI Joint Fusion System — Aegis Spine, Inc. · Class II
- SI-LUTION Sacroiliac Joint Fusion System — Curiteva, LLC · Class II
Cleared under the same submission
K251075 also covers:
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE
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
- Promethean Restorative
Sources (1)
- FDA UDI 6aecdf72-1522-4939-a79e-44a4fe374b73 37 fields · synced May 30, 2026