FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BridalVeil Navigated Instruments
K Number: K182982
·
Decision Jan 4, 2019
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
21
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BridalVeil Navigated Instruments
- K Number
- K182982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astura Medical
- Date Received
- October 29, 2018
- Decision Date
- January 4, 2019
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.
Dynamis Robotic Surgical System
FDA 510(k)
FDA Class 2
·Neurology
CORUS Navigation System-GN
FDA 510(k)
FDA Class 2
·Neurology
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Navigated LLIF Impactable Tracker
FDA 510(k)
FDA Class 2
·Neurology
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
FDA 510(k)
FDA Class 2
·Neurology
Ion-C Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Astura Medical
| K Number | Device Name | ||
|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Jan 22, 2026 | Substantially Equivalent |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Oct 21, 2025 | Substantially Equivalent |
| K243259 | MASADA Modular Spinal Fixation System | Jan 7, 2025 | Substantially Equivalent |
| K240160 | EGPS Navigated Instruments | Oct 17, 2024 | Substantially Equivalent |
| K233359 | DOMINION Expandable Corpectomy System | Mar 8, 2024 | Substantially Equivalent |
| K231694 | MASADA Modular Spinal Fixation System | Nov 16, 2023 | Substantially Equivalent |
| K232211 | REUNION Sacroiliac Joint Fusion System | Oct 24, 2023 | Substantially Equivalent |
| K223335 | SIRION Lateral Lumbar Interbody System | May 9, 2023 | Substantially Equivalent |
| K222097 | OLYMPIC Deformity Band System | May 4, 2023 | Substantially Equivalent |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Jan 19, 2023 | Substantially Equivalent |