FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATEC Universal Spacer System
K Number: K180480
·
Decision May 31, 2018
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
2
Applicant Total
93
Review Days
97
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Basic Information
- Device Name
- ATEC Universal Spacer System
- K Number
- K180480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphatec Spine, Inc.
- Date Received
- February 23, 2018
- Decision Date
- May 31, 2018
- Product Code
- PHM
- 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 |
|---|---|---|---|
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHM), ordered by most recent decision date.
Battalion Universal Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
NuVasive CoRoent Thoracolumbar Implants
FDA 510(k)
FDA Class 2
·Orthopedic
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