Identity
- Trade Name
- Sacroiliac Joint Fusion System FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- SI Retractable Lateral Decorticator FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- SI Retractable Lateral Decorticator FDA UDI
Identifiers
- Catalog Number
- GSI201 FDA UDI
- Primary DI / UDI-DI
- M719GSI2010 FDA UDI
- 510(k) Number
- K191748 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Bone awl, reusable 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
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: Bone awl, reusable
Sacroiliac Joint Fusion System by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone awl, reusable.
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Cleared under the same submission
K191748 also covers:
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC
- Sacroiliac Joint Fusion System — Genesys Orthopedics 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
- Genesys Orthopedics Systems LLC
Sources (1)
- FDA UDI 2184cbae-6d7c-4178-82b5-a3a5b13a8c52 36 fields · synced May 31, 2026