FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CxHA PEEK Cervical IBF System
K Number: K181115
·
Decision Jul 16, 2018
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
33
Review Days
80
Basic Information
- Device Name
- CxHA PEEK Cervical IBF System
- K Number
- K181115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovasis, Inc.
- Date Received
- April 27, 2018
- Decision Date
- July 16, 2018
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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