FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
K Number: K143572
·
Decision Jun 10, 2015
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
3
Review Days
175
Basic Information
- Device Name
- Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
- K Number
- K143572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed Implantes, Ltda
- Date Received
- December 17, 2014
- Decision Date
- June 10, 2015
- 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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