FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTRA-OCT Spine System
K Number: K181350
·
Decision Jul 6, 2018
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
12
Review Days
45
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Basic Information
- Device Name
- ASTRA-OCT Spine System
- K Number
- K181350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinecraft, LLC
- Date Received
- May 22, 2018
- Decision Date
- July 6, 2018
- Product Code
- NKG
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKG), ordered by most recent decision date.
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ANAX OCT Spinal System
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Other Clearances by Spinecraft, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System | Jul 20, 2023 | Substantially Equivalent |
| 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 |
| 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 |