FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K Number: K132582
·
Decision Feb 12, 2014
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
186
Review Days
180
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Basic Information
- Device Name
- EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
- K Number
- K132582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- August 16, 2013
- Decision Date
- February 12, 2014
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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