BridalVeil Navigated Instruments
510(k) K182982
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182982 | Date4 Jan 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The BridalVeil Navigated Instruments are orthopedic stereotaxic instruments designed for spinal navigation and fixation procedures. These instruments facilitate precise placement of implants in complex posterior craniocervical, cervical, and thoracic spinal anatomy, supporting surgical interventions requiring spinal stabilization.
Supplied as a reusable set, these instruments are intended for use in operating room environments and are regulated under FDA 510(k) clearance (K182982). They fall under the OLO product code classification and are authorized for use in spinal surgeries where navigated fixation is required. No additional sterility or single-use specifications are noted in the provided data.
Other devices from Astura Medical
Questions
AI-generated answers, 19 Sep 2026
What types of spinal surgeries are these instruments specifically designed for, and why are they considered navigated?
The BridalVeil Navigated Instruments are designed for spinal navigation and fixation procedures in complex posterior craniocervical, cervical, and thoracic spinal anatomy. They are considered navigated because they assist surgeons in achieving precise implant placement, reducing reliance on freehand techniques and improving accuracy in stabilizing spinal segments during surgery.
Are these instruments reusable or single-use, and what does that mean for their maintenance and sterilization?
The BridalVeil Navigated Instruments are supplied as a reusable set, meaning they are intended for repeated use across multiple procedures. Since they are not labeled as single-use, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality between uses, as outlined in the manufacturer’s instructions.
How do I determine which size or model of these instruments is appropriate for my patient’s procedure?
The BridalVeil Navigated Instruments are designed for complex spinal fixation procedures, but the exact sizing or model selection is not detailed in the provided data. Typically, the choice depends on the specific anatomical requirements of the patient’s surgery, such as the curvature or segment of the spine being addressed. Consulting the manufacturer’s documentation or a surgical specialist would be recommended to ensure compatibility.
What regulatory pathway was followed for FDA clearance of these instruments, and what does that mean for their use in clinical settings?
The BridalVeil Navigated Instruments received FDA clearance through a 510(k) submission (K182982), which means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device. This clearance indicates that the instruments meet FDA safety and effectiveness requirements for spinal navigation and fixation, allowing their use in clinical settings for the specified procedures under the guidance of trained professionals.