FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Biomet Fusion System
K Number: K163543
·
Decision Feb 28, 2017
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
15
Review Days
74
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Basic Information
- Device Name
- Biomet Fusion System
- K Number
- K163543
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer Biomet Spine, Inc.
- Date Received
- December 16, 2016
- Decision Date
- February 28, 2017
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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| K210275 | Polaris Spinal System | Apr 2, 2021 | Substantially Equivalent |
| K203507 | Vitality® Spinal Fixation System | Jan 28, 2021 | Substantially Equivalent |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System | Oct 8, 2020 | Substantially Equivalent |
| K191722 | Vital Navigation System | Dec 2, 2019 | Substantially Equivalent |
| K192133 | Zimmer Biomet Universal Navigation System | Oct 29, 2019 | Substantially Equivalent |
| K190556 | Zimmer Biomet Universal Navigation System | Oct 24, 2019 | Substantially Equivalent |
| K183550 | Vitality® Spinal Fixation System | Apr 8, 2019 | Substantially Equivalent |
| K181096 | Avenue P Cage System | Jan 15, 2019 | Substantially Equivalent |