FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dark Star Navigation Instrument System
K Number: K212028
·
Decision Sep 27, 2021
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- Dark Star Navigation Instrument System
- K Number
- K212028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Republic Spine, LLC
- Date Received
- June 29, 2021
- Decision Date
- September 27, 2021
- 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 |
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|---|---|---|---|
| K223096 | Dark Star Deformity Pedicle Screw System | May 26, 2023 | Substantially Equivalent |
| K201420 | Republic Spine Dark Star Spinal System | Mar 5, 2021 | Substantially Equivalent |
| K190398 | Republic Spine Restore Intervertebral Body Fusion System | Sep 12, 2019 | Substantially Equivalent |
| K190889 | Republic Spine Restore Cervical Interbody Fusion System | Jun 19, 2019 | Substantially Equivalent |
| K181495 | Republic Spine Dark Star Spinal System | Jul 25, 2018 | Substantially Equivalent |
| K150283 | Republic Spine Dark Star Spinal System | Apr 29, 2015 | Substantially Equivalent |