Identity
- Trade Name
- Sacroiliac Joint Fusion System FDA UDI
- Generic Name
- Intraoperative bone pin/screw, non-sterile FDA UDI
- Device Name
- SI 1-pc Targeting Pin Long - Trocar Tip FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- SI 1-pc Targeting Pin Long - Trocar Tip FDA UDI
Identifiers
- Catalog Number
- GSI211-01L FDA UDI
- Primary DI / UDI-DI
- M719GSI21101L0 FDA UDI
- 510(k) Number
- K191748 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Intraoperative bone pin/screw, non-sterile 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: Intraoperative bone pin/screw, non-sterile
Sacroiliac Joint Fusion System by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative bone pin/screw, non-sterile.
- Maxima™ ACP System — CG MedTech Co., Ltd. · Class I
- GPS — Exactech, Inc. · Class I
- Vantage — Exactech, Inc. · Class I
- Steinmann Pin Single Trocar Round 12" 2.4MM — BIOPRO, INC. · Class II
- Vantage — Exactech, Inc. · Class I
- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- MATIRA ANTERIOR CERVICAL SYSTEM — Kalitec Direct LLC · Class I
- ASPIRON S ACP SYSTEM — CG MedTech Co., Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genesys Orthopedics Systems LLC
Sources (1)
- FDA UDI 0eb7bae9-38bc-44fe-96a0-d0813c96dafd 36 fields · synced Jun 7, 2026