FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
InTice-C Porous Ti Cervical Interbody System
K Number: K173832
·
Decision May 17, 2018
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
34
Review Days
150
Basic Information
- Device Name
- InTice-C Porous Ti Cervical Interbody System
- K Number
- K173832
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- X-Spine Systems, Inc.
- Date Received
- December 18, 2017
- Decision Date
- May 17, 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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