FDA 510(k)
Substantially Equivalent
🇺🇸 United States
Calibrate Interbody Systems
K Number: K243461
·
Decision Mar 4, 2025
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
93
Review Days
116
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Basic Information
- Device Name
- Calibrate Interbody Systems
- K Number
- K243461
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphatec Spine, Inc.
- Date Received
- November 8, 2024
- Decision Date
- March 4, 2025
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
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