Identity
- Trade Name
- Sacroiliac Joint Fusion System FDA UDI
- Generic Name
- Bone graft syringe, reusable FDA UDI
- Device Name
- Posterior SI Allograft Kit, Single, 20mm FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Posterior SI Allograft Kit, Single, 20mm FDA UDI
Identifiers
- Catalog Number
- PM1020 FDA UDI
- Primary DI / UDI-DI
- M719PM10200 FDA UDI
- 510(k) Number
- K191748 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Bone graft syringe, 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 graft syringe, reusable
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 Bone graft syringe, reusable.
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- GRAFT MATERIAL CARRIER D/E — W.H. Holden, Inc. · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- SPOON-COMPACTOR BONE INST. — W.H. Holden, Inc. · Class I
- SPOON COMPACTOR BONE INST 4mm — W.H. Holden, Inc. · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- GRAFT MATERIAL SPATULA / CARRIER — W.H. Holden, Inc. · Class I
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
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 7a0ada06-538a-4567-a9b8-84914778e0c4 36 fields · synced May 30, 2026