Identity
- Trade Name
- Blue Topaz Sacroiliac Screw System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
- Device Name
- Sacroiliac Screw, 8.5x55mm, Blue Topaz FDA UDI
- Model / Reference
- 3000-08555 FDA UDI
- Description
- Sacroiliac Screw, 8.5x55mm, Blue Topaz FDA UDI
Identifiers
- Catalog Number
- 3000-08555 FDA UDI
- Primary DI / UDI-DI
- B062300008555 FDA UDI
- 510(k) Number
- K213590 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Blue Topaz Sacroiliac Screw System by Osseus Fusion Systems 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.
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- SOLACE Sacroiliac Fixation System — Xenix Medical · Class II
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- SacroFuse — SPINEFRONTIER, INC. · Class II
- SI-LUTION Sacroiliac Joint Fusion System — Curiteva, LLC · Class II
- T-FIX™3Dsi Joint Fusion System — CUTTING EDGE SPINE · Class II
- Unity Erodium — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K213590 also covers:
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS LLC
- Blue Topaz Sacroiliac Screw System — OSSEUS FUSION SYSTEMS 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
- Osseus Fusion Systems Llc
Sources (1)
- FDA UDI c8192c98-d4a6-416a-8bd9-aff1b1c25454 35 fields · synced May 30, 2026