SAIL FUSION

FDA Device Registration & Listing · Del Mar, CA, US · Registration 3031024716

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031024716
FEI Number
3031024716
Entity Name
SAIL FUSION
City/State/Country
Del Mar, CA, US
Establishment Address
2010 Jimmy Durante Blvd Ste 200, Del Mar, CA 92014, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
SAIL Fusion (Owner Number: 10090703)
Owner / Operator Contact Address
2010 Jimmy Durante Blvd., Suite 200, Del Mar, CA 92014, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BowTie™ SI Joint Fusion System BowTie™ SI Joint Fusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2024-04-30
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-05-16

Official Correspondent

Alyson Ronald

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SAIL Fusion
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K213667 SI-BONE, Inc. iFuse-TORQ® Implant System 2022-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031024716. Last updated year: 2026. Please use registration number 3031024716 when referencing this establishment in official correspondence.
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