FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
K Number: K223301
·
Decision Jul 20, 2023
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
12
Review Days
266
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
- ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
- K Number
- K223301
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinecraft, LLC
- Date Received
- October 27, 2022
- Decision Date
- July 20, 2023
- 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 Spinecraft, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K223273 | ASTRA Spine System | Dec 22, 2022 | Substantially Equivalent |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Sep 30, 2021 | Substantially Equivalent |
| K211323 | ASTRA Spine System | Jun 3, 2021 | Substantially Equivalent |
| K181350 | ASTRA-OCT Spine System | Jul 6, 2018 | Substantially Equivalent |
| K143683 | APEX-DL Spine System | May 22, 2015 | Substantially Equivalent |
| K150417 | ASTRA SPINE SYSTEM | May 19, 2015 | Substantially Equivalent |
| K131521 | VELOX ANTERIOR CERVICAL PLATE SYSTEM | Dec 24, 2013 | Substantially Equivalent |
| K132603 | APEX SPINE SYSTEM | Nov 20, 2013 | Substantially Equivalent |
| K110906 | APEX SPINE SYSTEM | Jul 26, 2011 | Substantially Equivalent |
| K103505 | ALTUM ANTERIOR CERVICAL PLATE | Mar 15, 2011 | Substantially Equivalent |