FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
ostaPek Interbody Fusion Cages
K Number: K181963
·
Decision Nov 14, 2018
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
4
Review Days
114
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Basic Information
- Device Name
- ostaPek Interbody Fusion Cages
- K Number
- K181963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coligne AG
- Date Received
- July 23, 2018
- Decision Date
- November 14, 2018
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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