FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATAMARAN SI Joint Fusion System
K Number: K231944
·
Decision Aug 24, 2023
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
2
Review Days
55
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Basic Information
- Device Name
- CATAMARAN SI Joint Fusion System
- K Number
- K231944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tenon Medical, Inc.
- Date Received
- June 30, 2023
- Decision Date
- August 24, 2023
- Product Code
- OUR
- 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 |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUR), ordered by most recent decision date.
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Other Clearances by Tenon Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | Jun 13, 2018 | Substantially Equivalent |