Identity
- Trade Name
- BowTie SI Fusion System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
- Device Name
- Iliac Screw, 75mm FDA UDI
- Model / Reference
- 90-JFA-200075 FDA UDI
- Description
- Iliac Screw, 75mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850053568145 FDA UDI
- 510(k) Number
- K232149 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated 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
Yes
FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, coated
BowTie SI Fusion System by Sail Fusion — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, coated.
- SImmetry Implant, 12.5mm x 100mm — Paradigm Spine, LLC · Class II
- iFuse Granite Implant System — Si-Bone Inc. · Class II
- SImmetry Implant, 14.5mm x 75mm — Paradigm Spine, LLC · Class II
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International · Class II
- iFuse Bedrock Granite Implant System — Si-Bone Inc. · Class II
- SImmetry LAG Implant, 10.5mm x 105mm — Paradigm Spine, LLC · Class II
- SImmetry LAG Implant, 12.5mm x 90mm — Paradigm Spine, LLC · Class II
- iFuse TORQ Implant System — Si-Bone Inc. · Class II
Cleared under the same submission
K232149 also covers:
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
- BowTie SI Fusion System — SAIL FUSION
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
- Sail Fusion
Sources (1)
- FDA UDI 8c2fff51-7b52-4c78-9786-c6a65091a556 34 fields · synced May 30, 2026