FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
K Number: K211710
·
Decision Jul 30, 2021
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
57
Review Days
57
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Basic Information
- Device Name
- Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
- K Number
- K211710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthofix, Inc.
- Date Received
- June 3, 2021
- Decision Date
- July 30, 2021
- 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.
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
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CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
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Infinity OCT System
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CMORE® CT System; CMORE® CT System Navigated Instruments
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Infinity OCT System
FDA 510(k)
FDA Class 2
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ANAX OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Orthofix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | May 28, 2024 | Substantially Equivalent |
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System | Aug 31, 2021 | Substantially Equivalent |
| K210667 | FIREBIRD SI Fusion System | Mar 25, 2021 | Substantially Equivalent |
| K203342 | CONSTRUX Mini Ti Spacer System | Mar 18, 2021 | Substantially Equivalent |
| K203576 | FORZA Ti Spacer System | Mar 3, 2021 | Substantially Equivalent |
| K203138 | FIREBIRD SI Fusion System | Nov 18, 2020 | Substantially Equivalent |
| K202949 | CONSTRUX Mini PEEK Spacer System | Oct 29, 2020 | Substantially Equivalent |
| K202666 | CONSTRUX Mini PTC Spacer System | Oct 14, 2020 | Substantially Equivalent |
| K201664 | FIREBIRD SI Fusion System | Sep 15, 2020 | Substantially Equivalent |
| K201481 | Centurion POCT System | Jun 15, 2020 | Substantially Equivalent |