FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPACT Sacroiliac Joint Fixation System
K Number: K212903
·
Decision Dec 15, 2021
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
121
Applicant Total
26
Review Days
93
Basic Information
- Device Name
- SIMPACT Sacroiliac Joint Fixation System
- K Number
- K212903
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Spine, Inc.
- Date Received
- September 13, 2021
- Decision Date
- December 15, 2021
- 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 |
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