FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CervAlign® Anterior Cervical Plate System
K Number: K211408
·
Decision Jun 23, 2021
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
26
Review Days
48
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Basic Information
- Device Name
- CervAlign® Anterior Cervical Plate System
- K Number
- K211408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pioneer Surgical Technology, Inc.
- Date Received
- May 6, 2021
- Decision Date
- June 23, 2021
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
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|---|---|---|---|
| K251436 | Resolve Anterior Cervical Plate System | Jul 11, 2025 | Substantially Equivalent |
| K222493 | CODA Anterior Cervical Plate System | Nov 18, 2022 | Substantially Equivalent |
| K192396 | Streamline MIS Spinal Fixation System | Nov 26, 2019 | Substantially Equivalent |
| K140696 | STREAMLINE TL SPINAL FIXATION SYSTEM | Apr 10, 2014 | Substantially Equivalent |
| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | Mar 27, 2014 | Substantially Equivalent |
| K133623 | C-PLUS | Feb 10, 2014 | Substantially Equivalent |
| K132050 | NB3D BONE VOID FILLER | Feb 7, 2014 | Substantially Equivalent |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | Jan 27, 2014 | Substantially Equivalent |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | Dec 24, 2013 | Substantially Equivalent |
| K131100 | STREAMLINE TL SPINAL SYSTEM | Jun 27, 2013 | Substantially Equivalent |