FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reform® POCT System
K Number: K172495
·
Decision Apr 11, 2018
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
24
Review Days
236
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Basic Information
- Device Name
- Reform® POCT System
- K Number
- K172495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Spine, Inc.
- Date Received
- August 18, 2017
- Decision Date
- April 11, 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 |
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|---|---|---|---|
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| K220862 | E-GPS Navigated Instruments | Jul 14, 2022 | Substantially Equivalent |
| K213118 | Dakota ALIF System | Apr 1, 2022 | Substantially Equivalent |
| K220324 | AccuFit Lateral 2-Hole Plate | Mar 16, 2022 | Substantially Equivalent |
| K212075 | ShurFit Lumbar Interbody System | Dec 8, 2021 | Substantially Equivalent |
| K212937 | Dakota ALIF Plate System | Nov 4, 2021 | Substantially Equivalent |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | Jan 12, 2021 | Substantially Equivalent |
| K181606 | Precision Spine Navigation Instrumentation | Sep 27, 2019 | Substantially Equivalent |